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Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00106028
Recruitment Status : Completed
First Posted : March 21, 2005
Results First Posted : June 28, 2010
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteogenesis Imperfecta
Interventions Drug: risedronate sodium (Actonel)
Drug: Placebo
Enrollment 143
Recruitment Details 147 children > or = 4 and < 16 years of age with Osteogenesis Imperfecta (OI) enrolled at 20 North American and international study centers starting 16NOV2004. Patients weighing 10-30 kg received risedronate 2.5 mg or placebo daily and patients weighing more than 30 kg received risedronate 5 mg or placebo daily.
Pre-assignment Details  
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description placebo tablet, once a day for one year then for two years open label risedronate risedronate tablet, once a day for one year then for two years open label risedronate once a day
Period Title: Overall Study
Started 49 [1] 94 [1]
Month 12 Completed/Started Open Label 49 87
Completed 43 [2] 82 [2]
Not Completed 6 12
Reason Not Completed
Adverse Event             3             2
Protocol Violation             1             1
Withdrawal by Subject             2             8
Lost to Follow-up             0             1
[1]
ITT Population: Patients Randomized and Received at least 1 Dose of Study Drug
[2]
Completed Month 36
Arm/Group Title Placebo Daily Risedronate Daily Total
Hide Arm/Group Description placebo tablet, once a day for one year then for two years open label risedronate risedronate tablet, once a day for one year then for two years open label risedronate once a day Total of all reporting groups
Overall Number of Baseline Participants 49 94 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 94 participants 143 participants
<=18 years
49
 100.0%
94
 100.0%
143.0
Between 18 and 65 years
0
   0.0%
0
   0.0%
0.0
>=65 years
0
   0.0%
0
   0.0%
0.0
[1]
Measure Description: There were 147 children enrolled in the study (stated in the protocol). However, 4 children were randomized but did not receive a dose of the study drug. Therefore, only 143 received at least 1 dose of study drug.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 94 participants 143 participants
8.6  (3.1) 8.9  (3.4) 8.825  (3.313)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 94 participants 143 participants
Female
22
  44.9%
49
  52.1%
71.0
Male
27
  55.1%
45
  47.9%
72.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 94 participants 143 participants
Australia 8 16 24
Belgium 1 1 2
Chile 4 9 13
Czech Republic 1 4 5
Finland 5 7 12
Germany 5 8 13
Hungary 2 2 4
Italy 1 2 3
Poland 5 9 14
South Africa 0 1 1
Spain 1 1 2
United Kingdom 9 21 30
United States 7 13 20
1.Primary Outcome
Title Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
Hide Description Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
7.592
(5.106 to 10.078)
16.159
(14.295 to 18.024)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.567
Confidence Interval 95%
5.590 to 11.545
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population
Hide Description Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
21.316
(17.357 to 25.275)
25.754
(22.860 to 28.648)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0625
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.438
Confidence Interval (2-Sided) 95%
-0.235 to 9.111
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population
Hide Description Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
33.216
(28.191 to 38.241)
34.753
(31.076 to 38.429)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6103
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.537
Confidence Interval (2-Sided) 95%
-4.424 to 7.497
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Total Body BMD at Month 12, ITT Population
Hide Description Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
4.252
(2.762 to 5.743)
5.806
(4.740 to 6.872)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0808
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.554
Confidence Interval 95%
-0.193 to 3.301
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Total Body BMD at Month 24, ITT Population
Hide Description Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
9.716
(7.897 to 11.535)
10.214
(8.899 to 11.528)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6466
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.498
Confidence Interval (2-Sided) 95%
-1.648 to 2.644
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in Total Body BMD at Month 36, ITT Population
Hide Description Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
13.540
(11.204 to 15.876)
13.076
(11.374 to 14.777)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7391
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.465
Confidence Interval (2-Sided) 95%
-3.224 to 2.294
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
17.885
(13.645 to 22.124)
28.218
(25.038 to 31.398)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments LS Means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.333
Confidence Interval 95%
5.258 to 15.408
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
42.367
(34.871 to 49.863)
48.407
(42.921 to 53.894)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 01789
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.040
Confidence Interval (2-Sided) 95%
-2.807 to 14.887
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
68.054
(57.564 to 78.544)
68.333
(60.607 to 76.060)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9646
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.280
Confidence Interval (2-Sided) 95%
-12.196 to 12.755
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in Total Body BMC at Month 12, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
16.483
(13.395 to 19.570)
21.977
(19.772 to 24.181)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.494
Confidence Interval 95%
1.912 to 9.077
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Change From Baseline in Total Body BMC at Month 24, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
36.465
(31.582 to 41.347)
37.938
(34.406 to 41.470)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6106
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.473
Confidence Interval (2-Sided) 95%
-4.245 to 7.192
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in Total Body BMC at Month 36, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
56.211
(49.470 to 62.952)
56.526
(51.549 to 61.503)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9372
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.315
Confidence Interval (2-Sided) 95%
-7.598 to 8.229
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population
Hide Description Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
-6.028
(-14.899 to 2.844)
25.648
(18.993 to 32.302)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted for baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 31.675
Confidence Interval 95%
21.051 to 42.300
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population
Hide Description Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
15.608
(2.327 to 28.889)
29.637
(19.911 to 39.363)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0793
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 14.029
Confidence Interval (2-Sided) 95%
-1.667 to 29.726
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population
Hide Description Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
19.325
(5.162 to 33.488)
25.640
(15.313 to 35.967)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4575
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.315
Confidence Interval (2-Sided) 95%
-10.477 to 23.107
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population
Hide Description Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, Population Description Number of Participants Analyzed = Number of participants at baseline and LOCF data
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
-20.661
(-47.090 to 5.769)
16.933
(-1.793 to 35.660)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0172
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 37.594
Confidence Interval 95%
6.801 to 68.386
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population
Hide Description Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
8.371
(-22.631 to 39.373)
7.879
(-14.273 to 30.032)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9786
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.492
Confidence Interval (2-Sided) 95%
-36.807 to 35.824
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population
Hide Description Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
7.146
(-20.474 to 34.766)
-1.494
(-21.400 to 18.411)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5971
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.640
Confidence Interval (2-Sided) 95%
-40.952 to 23.672
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population
Hide Description Measured by DXA.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
8.803
(6.751 to 10.856)
9.817
(8.278 to 11.356)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4154
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.014
Confidence Interval 95%
-1.442 to 3.470
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population
Hide Description Measured by DXA.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
16.381
(13.214 to 19.549)
17.266
(14.945 to 19.586)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6404
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.884
Confidence Interval (2-Sided) 95%
-2.855 to 4.623
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population
Hide Description Measured by DXA.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
24.952
(20.877 to 29.027)
23.292
(20.296 to 26.289)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4978
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.660
Confidence Interval (2-Sided) 95%
-6.499 to 3.179
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
11.405
(8.708 to 14.101)
14.939
(13.028 to 16.850)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0270
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.534
Confidence Interval 95%
0.410 to 6.658
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
24.051
(20.684 to 27.417)
25.116
(22.699 to 27.533)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5925
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.065
Confidence Interval (2-Sided) 95%
-2.868 to 4.998
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population
Hide Description [Not Specified]
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
37.109
(32.144 to 42.074)
38.303
(34.674 to 41.931)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6840
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.193
Confidence Interval (2-Sided) 95%
-4.604 to 6.991
Estimation Comments [Not Specified]
25.Secondary Outcome
Title New Morphometric Vertebral Fracture at Month 12, ITT Population
Hide Description Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Measure Type: Number
Unit of Measure: Participants
At Least One New Fracture Vertebra 8 28
No New Fractured Vertebra 40 60
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0680
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
26.Secondary Outcome
Title New Morphometric Vertebral Fracture at Month 36, ITT Population
Hide Description Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Measure Type: Number
Unit of Measure: Participants
At Least One New Fracture Vertebra 14 20
No New Fractured Vertebra 31 62
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4121
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
27.Secondary Outcome
Title Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT
Hide Description Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Measure Type: Number
Unit of Measure: Participants
No New Fractured Vertebra 40 60
One Fractured Vertebra 3 17
Two Fractured Vertebra 2 8
Three or more Fractured Vertebra 3 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3658
Comments [Not Specified]
Method Savage Exact Test
Comments [Not Specified]
28.Secondary Outcome
Title Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT
Hide Description Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Measure Type: Number
Unit of Measure: Participants
No New Fractured Vertebra 31 62
One Fractured Vertebra 6 10
Two Fractured Vertebra 5 7
Three or more Fractured Vertebra 3 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3408
Comments [Not Specified]
Method Savage Exact Test
Comments [Not Specified]
29.Secondary Outcome
Title Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population
Hide Description Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, Number of Participants Analyzed = Number of participants with baseline and Month 12 data
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 28 53
Measure Type: Number
Unit of Measure: Participants
Number Patients with New Vertebral Fractures 7 19
Number of New Vertebral Fractures 19 32
Number Patients New Fractures & Mild SQ Score 7 17
Number Patients New Fractures & Mod/Sev SQ Score 3 3
30.Secondary Outcome
Title Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population
Hide Description Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 21 41
Measure Type: Number
Unit of Measure: Participants
Number Patients with New Vertebral Fractures 1 10
Number of New Vertebral Fractures 1 13
Number Patients New Fractures & Mild SQ Score 1 10
Number Patients New Fractures & Mod/Sev SQ Score 0 1
31.Secondary Outcome
Title Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population
Hide Description Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Time Frame Time to First Event (days) up to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Measure Type: Number
Unit of Measure: Probability of Fractures
Number Patients All Fractures 24 29
All Fractures/Kaplan-Meier Cumulative Incidence 0.5043 0.314
Number Patients Vertebral Fractures 0 0
Vertebral Fractures/Kaplan-Meier Cumulative Incid. 0 0
Number Patients Non-Vertebral Fractures 24 29
Non-Vertebral Fractures/Kaplan-Meier Cum. Incid. 0.5043 0.314
Number Patients Long Bone Non-Vertebral Fractures 17 18
Long Bone Non-Vertebral Fractures/Kaplan-Meier Cum 0.3618 0.1954
Number Patients Other Non-Vertebral Fractures 10 12
Other Non-Vertebral Fractures/Kaplan-Meier Cum. 0.204 0.1311
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0253
Comments All Fractures
Method Cox proportional hazards
Comments Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.534
Confidence Interval 95%
0.310 to 0.922
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0253
Comments All Non-Vertebral Fractures
Method Cox Proportional Hazard
Comments Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.534
Confidence Interval (2-Sided) 95%
0.310 to 0.922
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0501
Comments Long Bone Non-Vertebral Fracture
Method Cox Proportional Hazards
Comments Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.487
Confidence Interval (2-Sided) 95%
0.250 to 0.950
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2141
Comments Other Non-Vertebral Fracture
Method Cox Proportional Hazard
Comments Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.608
Confidence Interval (2-Sided) 95%
0.262 to 1.410
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Number of Clinical Fractures, Month 12, ITT Population
Hide Description Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Measure Type: Number
Unit of Measure: Participants
Number of Fractures 38 42
Number of Patients with Fractures 24 29
Number of Vertebral Fractures 0 0
Number Patients with Vertebral Fractures 0 0
Number of Non-Vertebral Fractures 38 42
Number Patients with Non-Vertebral Fractures 24 29
Number Long-Bone Non-Vertebral Fractures 27 28
Number Patients Long-Bone Non-Vertebral Fractures 17 18
Number Other Non-Vertebral Fractures 11 14
Number Patients with Other Non-Vertebral Fractures 10 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0416
Comments All Fractures
Method Wald test
Comments Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.584
Confidence Interval 95%
0.348 to 0.980
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0416
Comments Non-Vertebral Fracture
Method Wald Test
Comments Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.584
Confidence Interval (2-Sided) 95%
0.348 to 0.980
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0799
Comments Long Bone Non-Vertebral Fracture
Method Wald Test
Comments Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.543
Confidence Interval (2-Sided) 95%
0.274 to 1.076
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.682
Comments Other Non-Vertebral Fracture
Method Wald Test
Comments Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.682
Confidence Interval (2-Sided) 95%
0.304 to 1.532
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Serum BAP - Percent Change From Baseline to Month 12, ITT Population
Hide Description Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time Frame Baseline and 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
6.783
(-2.107 to 15.674)
-4.895
(-11.509 to 1.719)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0318
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.678
Confidence Interval 95%
-22.325 to -1.031
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Serum BAP - Percent Change From Baseline to Month 24, ITT Population
Hide Description Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time Frame Baseline and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-11.196
(-20.748 to -1.643)
-11.128
(-18.286 to -3.971)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9907
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.067
Confidence Interval (2-Sided) 95%
-11.401 to 11.536
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Serum BAP - Percent Change From Baseline to Month 36, ITT Population
Hide Description Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Time Frame Baseline and 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-19.884
(-28.658 to -11.109)
-24.570
(-31.304 to -17.836)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3826
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.686
Confidence Interval (2-Sided) 95%
-15.276 to 5.903
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population
Hide Description Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time Frame Baseline and Endpoint / Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-14.556
(-24.218 to -4.894)
-41.185
(-48.625 to -33.745)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -26.629
Confidence Interval 95%
-38.089 to -15.169
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population
Hide Description Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-40.358
(-54.722 to -25.994)
-31.318
(-42.478 to -20.158)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3075
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.040
Confidence Interval (2-Sided) 95%
-8.433 to 26.512
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population
Hide Description Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-47.570
(-57.317 to -37.823)
-52.609
(-60.203 to -45.015)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3998
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.039
Confidence Interval (2-Sided) 95%
-16.849 to 6.772
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population
Hide Description Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
-0.056
(-0.471 to 0.358)
-0.409
(-0.712 to -0.106)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1592
Comments [Not Specified]
Method ANCOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.352
Confidence Interval 95%
-0.845 to 0.140
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Bone Age (Years), Change From Baseline to Month 12, ITT Population
Hide Description Bone Age determined by visual assessment of hand / wrist radiographs.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Years
0.956
(0.756 to 1.155)
1.083
(0.935 to 1.231)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2917
Comments [Not Specified]
Method ANOVA
Comments LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.127
Confidence Interval 95%
-0.111 to 0.365
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Bone Age (Years), Change From Baseline to Month 24, ITT Population
Hide Description Bone Age determined by visual assessment of hand / wrist radiographs.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Years
2.147
(1.888 to 2.407)
2.155
(1.962 to 2.347)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9622
Comments [Not Specified]
Method ANOVA
Comments LS mean and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.007
Confidence Interval 95%
-0.304 to 0.319
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Bone Age (Years), Change From Baseline to Month 36, ITT Population
Hide Description Bone Age determined by visual assessment of hand / wrist radiographs.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Years
3.087
(2.800 to 3.374)
3.096
(2.879 to 3.312)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9596
Comments [Not Specified]
Method ANOVA
Comments LS means and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.009
Confidence Interval (2-Sided) 95%
-0.336 to 0.354
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population
Hide Description Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Change in Annualized Growth Velocity
0.895
(0.709 to 1.080)
1.002
(0.865 to 1.138)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3400
Comments [Not Specified]
Method ANOVA
Comments LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.107
Confidence Interval 95%
-0.114 to 0.328
Estimation Comments [Not Specified]
44.Secondary Outcome
Title Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population
Hide Description Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data
Arm/Group Title Placebo Daily Risedronate Daily
Hide Arm/Group Description:
placebo tablet, once a day for one year then for two years open label risedronate
risedronate tablet, once a day for one year then for two years open label risedronate once a day
Overall Number of Participants Analyzed 49 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Change in Annualized Growth Velocity
0.982
(0.886 to 1.077)
1.011
(0.941 to 1.081)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Daily, Risedronate Daily
Comments A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6218
Comments [Not Specified]
Method ANOVA
Comments LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.029
Confidence Interval (2-Sided) 95%
-0.084 to 0.142
Estimation Comments [Not Specified]
Time Frame 36 months: One year double-blind treatment, 2 years open-label risedronate treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Daily Risedronate Daily Years 2 & 3 Placebo-Risedronate Years 2 & 3 Risedronate
Hide Arm/Group Description placebo tablet, once a day for one year then for two years open label risedronate risedronate tablet, once a day for one year then for two years open label risedronate once a day Year 1 Placebo Double-Blind, Years 2 & 3 Open-Label Risedronate Years 1-3 Risedronate, Double-Blind Year 1, Open-Label Years 2 & 3
All-Cause Mortality
Placebo Daily Risedronate Daily Years 2 & 3 Placebo-Risedronate Years 2 & 3 Risedronate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Daily Risedronate Daily Years 2 & 3 Placebo-Risedronate Years 2 & 3 Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/49 (16.33%)      11/94 (11.70%)      13/49 (26.53%)      16/87 (18.39%)    
Cardiac disorders         
Palpitations  1  0/49 (0.00%)  0 0/94 (0.00%)  0 1/49 (2.04%)  1 0/87 (0.00%)  0
Ear and labyrinth disorders         
Tympanic Membrane Perforation  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Gastrointestinal disorders         
Crohn's disease  1  0/49 (0.00%)  0 1/94 (1.06%)  1 0/49 (0.00%)  0 0/87 (0.00%)  0
Gastritis  1  0/49 (0.00%)  0 1/94 (1.06%)  1 0/49 (0.00%)  0 0/87 (0.00%)  0
General disorders         
Device Failure  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Infections and infestations         
Cellulitis  1  0/49 (0.00%)  0 1/94 (1.06%)  1 1/49 (2.04%)  1 0/87 (0.00%)  0
Mastoiditis  1  0/49 (0.00%)  0 1/94 (1.06%)  1 0/49 (0.00%)  0 0/87 (0.00%)  0
Gastroenteritis  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Pneumonia  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Tonsillitis  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Injury, poisoning and procedural complications         
Femur fracture  1  7/49 (14.29%)  8 4/94 (4.26%)  7 6/49 (12.24%)  7 3/87 (3.45%)  5
Forearm fracture  1  0/49 (0.00%)  0 2/94 (2.13%)  2 1/49 (2.04%)  1 1/87 (1.15%)  1
Tibia fracture  1  2/49 (4.08%)  2 2/94 (2.13%)  2 1/49 (2.04%)  1 2/87 (2.30%)  2
Fibula fracture  1  1/49 (2.04%)  1 1/94 (1.06%)  1 1/49 (2.04%)  1 1/87 (1.15%)  1
Ulna fracture  1  2/49 (4.08%)  2 1/94 (1.06%)  1 2/49 (4.08%)  2 2/87 (2.30%)  3
Upper limb fracture  1  0/49 (0.00%)  0 1/94 (1.06%)  1 0/49 (0.00%)  0 1/87 (1.15%)  1
Lower limb fracture  1  1/49 (2.04%)  2 0/94 (0.00%)  0 0/49 (0.00%)  0 0/87 (0.00%)  0
Radius fracture  1  2/49 (4.08%)  2 0/94 (0.00%)  0 2/49 (4.08%)  2 0/87 (0.00%)  0
Wrist fracture  1  1/49 (2.04%)  1 0/94 (0.00%)  0 0/49 (0.00%)  0 0/87 (0.00%)  0
Concussion  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Humerus Fracture  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Ilium Fracture  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Pelvic Fracture  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Rib Fracture  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Cervical Vertebral Fracture  1  0/49 (0.00%)  0 0/94 (0.00%)  0 1/49 (2.04%)  1 0/87 (0.00%)  0
Hand Fracture  1  0/49 (0.00%)  0 0/94 (0.00%)  0 1/49 (2.04%)  1 0/87 (0.00%)  0
Patella Fracture  1  0/49 (0.00%)  0 0/94 (0.00%)  0 1/49 (2.04%)  1 0/87 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back Pain  1  0/49 (0.00%)  0 0/94 (0.00%)  0 0/49 (0.00%)  0 1/87 (1.15%)  1
Scoliosis  1  0/49 (0.00%)  0 0/94 (0.00%)  0 1/49 (2.04%)  1 0/87 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign Bone Neoplasm  1  0/49 (0.00%)  0 0/94 (0.00%)  0 1/49 (2.04%)  1 0/87 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Daily Risedronate Daily Years 2 & 3 Placebo-Risedronate Years 2 & 3 Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/49 (95.92%)      86/94 (91.49%)      46/49 (93.88%)      79/87 (90.80%)    
Ear and labyrinth disorders         
Ear Pain  1  1/49 (2.04%)  1 0/94 (0.00%)  0 3/49 (6.12%)  3 1/87 (1.15%)  4
Eye disorders         
Eye disorders  1  3/49 (6.12%)  3 4/94 (4.26%)  6 3/49 (6.12%)  3 1/87 (1.15%)  1
Gastrointestinal disorders         
Vomiting  1  3/49 (6.12%)  5 14/94 (14.89%)  28 5/49 (10.20%)  13 5/87 (5.75%)  7
Abdominal pain upper  1  4/49 (8.16%)  6 10/94 (10.64%)  10 6/49 (12.24%)  7 3/87 (3.45%)  6
Abdominal pain  1  7/49 (14.29%)  14 8/94 (8.51%)  8 6/49 (12.24%)  6 5/87 (5.75%)  6
Diarrhoea  1  3/49 (6.12%)  3 6/94 (6.38%)  6 3/49 (6.12%)  4 7/87 (8.05%)  7
Nausea  1  6/49 (12.24%)  7 4/94 (4.26%)  4 4/49 (8.16%)  5 4/87 (4.60%)  4
General disorders         
Pain  1  5/49 (10.20%)  6 14/94 (14.89%)  16 1/49 (2.04%)  1 3/87 (3.45%)  5
Pyrexia  1  2/49 (4.08%)  2 8/94 (8.51%)  8 7/49 (14.29%)  8 5/87 (5.75%)  12
Immune system disorders         
Seasonal allergies  1  0/49 (0.00%)  0 5/94 (5.32%)  5 1/49 (2.04%)  2 3/87 (3.45%)  6
Infections and infestations         
Upper respiratory tract infection  1  3/49 (6.12%)  4 8/94 (8.51%)  13 4/49 (8.16%)  7 7/87 (8.05%)  9
Bronchitis  1  3/49 (6.12%)  7 7/94 (7.45%)  13 2/49 (4.08%)  5 8/87 (9.20%)  13
Nasopharyngitis  1  3/49 (6.12%)  3 7/94 (7.45%)  8 3/49 (6.12%)  3 9/87 (10.34%)  10
Respiratory tract infection  1  1/49 (2.04%)  2 6/94 (6.38%)  11 3/49 (6.12%)  10 7/87 (8.05%)  16
Influenza  1  2/49 (4.08%)  3 5/94 (5.32%)  6 2/49 (4.08%)  2 8/87 (9.20%)  8
Varicella  1  0/49 (0.00%)  0 5/94 (5.32%)  5 1/49 (2.04%)  1 0/87 (0.00%)  0
Otitis media  1  3/49 (6.12%)  3 3/94 (3.19%)  7 2/49 (4.08%)  2 1/87 (1.15%)  1
Tonsillitis  1  3/49 (6.12%)  3 3/94 (3.19%)  3 1/49 (2.04%)  1 3/87 (3.45%)  3
Gastroenteritis  1  5/49 (10.20%)  5 1/94 (1.06%)  1 4/49 (8.16%)  8 8/87 (9.20%)  9
Injury, poisoning and procedural complications         
Fall  1  14/49 (28.57%)  21 19/94 (20.21%)  24 22/49 (44.90%)  31 36/87 (41.38%)  55
Femur fracture  1  8/49 (16.33%)  9 9/94 (9.57%)  12 9/49 (18.37%)  11 4/87 (4.60%)  7
Joint sprain  1  4/49 (8.16%)  4 9/94 (9.57%)  12 3/49 (6.12%)  6 6/87 (6.90%)  6
Contusion  1  3/49 (6.12%)  3 6/94 (6.38%)  6 2/49 (4.08%)  2 7/87 (8.05%)  10
Foot fracture  1  1/49 (2.04%)  1 6/94 (6.38%)  7 5/49 (10.20%)  5 7/87 (8.05%)  7
Hand fracture  1  3/49 (6.12%)  3 5/94 (5.32%)  6 11/49 (22.45%)  11 12/87 (13.79%)  17
Tibia fracture  1  2/49 (4.08%)  3 5/94 (5.32%)  5 7/49 (14.29%)  11 7/87 (8.05%)  7
Joint injury  1  3/49 (6.12%)  4 4/94 (4.26%)  4 4/49 (8.16%)  6 5/87 (5.75%)  5
Limb injury  1  3/49 (6.12%)  5 3/94 (3.19%)  4 3/49 (6.12%)  3 4/87 (4.60%)  8
Ulna fracture  1  4/49 (8.16%)  5 2/94 (2.13%)  3 5/49 (10.20%)  6 9/87 (10.34%)  12
Muscle strain  1  3/49 (6.12%)  4 2/94 (2.13%)  3 1/49 (2.04%)  1 1/87 (1.15%)  1
Radius fracture  1  4/49 (8.16%)  5 1/94 (1.06%)  1 3/49 (6.12%)  3 11/87 (12.64%)  11
Wrist fracture  1  3/49 (6.12%)  3 0/94 (0.00%)  0 0/49 (0.00%)  0 2/87 (2.30%)  2
Humerus Fracture  1  0/49 (0.00%)  0 1/94 (1.06%)  1 3/49 (6.12%)  3 5/87 (5.75%)  6
Forearm Fracture  1  2/49 (4.08%)  2 3/94 (3.19%)  3 5/49 (10.20%)  6 3/87 (3.45%)  3
Clavicle Fracture  1  2/49 (4.08%)  2 0/94 (0.00%)  0 3/49 (6.12%)  3 2/87 (2.30%)  2
Fibula Fracture  1  2/49 (4.08%)  2 2/94 (2.13%)  2 4/49 (8.16%)  4 2/87 (2.30%)  2
Dyspepsia  1  1/49 (2.04%)  1 1/94 (1.06%)  1 3/49 (6.12%)  3 2/87 (2.30%)  2
Musculoskeletal and connective tissue disorders         
Pain in extremity  1  8/49 (16.33%)  8 20/94 (21.28%)  27 7/49 (14.29%)  7 11/87 (12.64%)  23
Back pain  1  5/49 (10.20%)  5 16/94 (17.02%)  20 7/49 (14.29%)  7 13/87 (14.94%)  20
Bone pain  1  2/49 (4.08%)  2 9/94 (9.57%)  11 2/49 (4.08%)  2 3/87 (3.45%)  4
Arthralgia  1  7/49 (14.29%)  11 8/94 (8.51%)  11 8/49 (16.33%)  11 5/87 (5.75%)  11
Musculoskeletal pain  1  2/49 (4.08%)  3 5/94 (5.32%)  5 4/49 (8.16%)  4 2/87 (2.30%)  3
Nervous system disorders         
Headache  1  4/49 (8.16%)  4 19/94 (20.21%)  25 4/49 (8.16%)  5 8/87 (9.20%)  13
Psychiatric disorders         
Psychiatric Disorders  1  1/49 (2.04%)  1 2/94 (2.13%)  2 3/49 (6.12%)  3 2/87 (2.30%)  2
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/49 (6.12%)  3 9/94 (9.57%)  17 4/49 (8.16%)  5 8/87 (9.20%)  18
Oropharyngeal pain  1  4/49 (8.16%)  4 5/94 (5.32%)  5 4/49 (8.16%)  4 2/87 (2.30%)  7
Skin and subcutaneous tissue disorders         
Skin and subcutaneous tissue disorders  1  4/49 (8.16%)  4 9/94 (9.57%)  9 6/49 (12.24%)  9 12/87 (13.79%)  14
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
The clinical meaningfulness of new fractures in the thoracic spine scored as Genant Grade I is unclear, thus the morphometric vertebral fracture data are evaluated further.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The findings of the study may be published in a scientific journal or presented at a scientific meeting. Before submitting the results of the study for publication or presentation, the Investigator will allow the Sponsor 30 days in which to review and comment on the manuscript.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
EMail: gwulff@wcrx.com
Layout table for additonal information
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00106028    
Other Study ID Numbers: 2003100
HMR4003I/3001
First Submitted: March 18, 2005
First Posted: March 21, 2005
Results First Submitted: April 15, 2009
Results First Posted: June 28, 2010
Last Update Posted: April 22, 2013