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Trial record 76 of 109 for:    Risedronate

Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00918749
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : March 24, 2011
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postmenopausal Osteoporosis
Interventions Drug: 150 mg
Drug: 75 mg
Drug: 100 mg
Enrollment 205
Recruitment Details Screening began 27 May 2009
Pre-assignment Details  
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Period Title: Overall Study
Started 70 66 69
ITT (Intent to Treat) Population 69 [1] 66 69
Completed 63 63 62
Not Completed 7 3 7
Reason Not Completed
Adverse Event             1             0             1
Lost to Follow-up             0             0             1
Withdrawal by Subject             5             3             5
No Study Medication Taken             1             0             0
[1]
One subject took no study drug and was not included in ITT Population
Arm/Group Title 150 mg 75 mg 100 mg Total
Hide Arm/Group Description 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast Total of all reporting groups
Overall Number of Baseline Participants 70 66 69 205
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 66 participants 69 participants 205 participants
58.3  (7.2) 58.2  (7.2) 57.5  (7.0) 58.0  (7.1)
[1]
Measure Description: ITT Population
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 66 participants 69 participants 205 participants
< 65 years 57 53 55 165
65 years thru <75 years 10 12 13 35
>= 75 years 2 1 1 4
[1]
Measure Description: ITT Population - Total 204
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 66 participants 69 participants 205 participants
Female
70
 100.0%
66
 100.0%
69
 100.0%
205
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 66 participants 69 participants 205 participants
Asian (Oriental) 7 6 3 16
Black 0 4 3 7
Caucasian 60 53 61 174
Multi-Racial 1 3 1 5
Hawaiian/Pacific Islander 1 0 1 2
[1]
Measure Description: ITT Population
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants 66 participants 69 participants 205 participants
70 66 69 205
1.Primary Outcome
Title Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population
Hide Description Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.
Time Frame Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 70 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-41.235  (2.995) -44.832  (3.012) -53.432  (3.025)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments A two group t-test with a 0.100 one-sided significance level would have 96% power to detect the difference between a risedronate 150 mg IRBB mean, µ1, of -46.000 and a risedronate 75 mg DRFB mean, µ2, of -29.900 (a difference in means of -16.100), assuming that the common SD was 28.000, with sample sizes of 60 per group, respectively. Estimates were based on Study 2005107 (35 mg DR once a week Phase 2 study). The sample size calculation was not adjusted for multiplicity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3946
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.598
Confidence Interval (2-Sided) 90%
-10.568 to 3.372
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.215
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 150 mg, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0045
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.197
Confidence Interval (2-Sided) 90%
-19.208 to -5.185
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.241
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
Hide Description [Not Specified]
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 69 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-38.407  (3.504) -33.641  (3.538) -38.625  (3.547)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3372
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.765
Confidence Interval (2-Sided) 90%
-3.421 to 12.952
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.952
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 150 mg, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9650
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.218
Confidence Interval (2-Sided) 90%
-8.427 to 7.991
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.966
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 69 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-35.591  (3.045) -35.203  (3.034) -46.379  (3.077)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9276
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.388
Confidence Interval (2-Sided) 90%
-6.670 to 7.447
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.269
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 150 mg, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.787
Confidence Interval (2-Sided) 90%
-17.917 to -3.657
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.313
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
Hide Description Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 69 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-15.365  (6.567) -0.837  (6.631) -1.150  (6.689)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1192
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 14.528
Confidence Interval (2-Sided) 90%
-0.813 to 29.868
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.280
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 150 mg, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1298
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 14.215
Confidence Interval (2-Sided) 90%
-1.230 to 29.659
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.343
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
Hide Description ITT Population
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 69 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-21.673  (4.351) -20.555  (4.326) -29.066  (4.356)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8546
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.119
Confidence Interval (2-Sided) 90%
-8.956 to 11.193
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.093
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 150 mg, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2291
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.393
Confidence Interval (2-Sided) 90%
-17.522 to 2.737
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.126
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
Hide Description ITT Population
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 69 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-13.447  (6.427) -7.942  (6.464) -14.360  (6.492)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5436
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.505
Confidence Interval (2-Sided) 90%
-9.452 to 20.462
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.046
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 150 mg, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9201
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.914
Confidence Interval (2-Sided) 90%
-15.959 to 14.132
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.100
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
Hide Description ITT Population
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 69 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-5.457  (2.867) -2.349  (2.895) -0.615  (2.902)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4440
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.108
Confidence Interval (2-Sided) 90%
-3.590 to 9.807
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.052
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 150 mg, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2349
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.842
Confidence Interval (2-Sided) 90%
-1.874 to 11.559
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.063
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
Hide Description ITT Population
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 69 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-17.797  (3.087) -12.831  (3.075) -12.872  (3.119)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2527
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.966
Confidence Interval (2-Sided) 90%
-2.189 to 12.120
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.327
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2613
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.926
Confidence Interval (2-Sided) 90%
-2.301 to 12.153
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.371
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
Hide Description ITT Population
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description:
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Number of Participants Analyzed 69 66 69
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from Baseline
-20.885  (2.956) -19.616  (2.973) -23.710  (2.986)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150 mg, 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7606
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.269
Confidence Interval (2-Sided) 90%
-5.609 to 8.148
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.160
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5006
Comments [Not Specified]
Method ANOVA
Comments Fixed effects for treatment and center.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.825
Confidence Interval (2-Sided) 90%
-9.744 to 4.095
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.185
Estimation Comments [Not Specified]
Time Frame 27 May 2009 thru 23 October 2009, 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 150 mg 75 mg 100 mg
Hide Arm/Group Description 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
All-Cause Mortality
150 mg 75 mg 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
150 mg 75 mg 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/69 (0.00%)      0/66 (0.00%)      0/69 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
150 mg 75 mg 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/69 (72.46%)      43/66 (65.15%)      49/69 (71.01%)    
Gastrointestinal disorders       
Diarrhoea  1  11/69 (15.94%)  14 15/66 (22.73%)  20 15/69 (21.74%)  18
Abdominal Pain  1  5/69 (7.25%)  5 16/66 (24.24%)  18 14/69 (20.29%)  19
Nausea  1  6/69 (8.70%)  8 6/66 (9.09%)  9 9/69 (13.04%)  12
Vomiting  1  3/69 (4.35%)  3 6/66 (9.09%)  6 6/69 (8.70%)  6
Constipation  1  4/69 (5.80%)  5 9/66 (13.64%)  9 5/69 (7.25%)  5
Dyspepsia  1  1/69 (1.45%)  1 4/66 (6.06%)  4 5/69 (7.25%)  6
Abdominal discomfort  1  2/69 (2.90%)  2 2/66 (3.03%)  2 4/69 (5.80%)  4
Flatulence  1  5/69 (7.25%)  5 2/66 (3.03%)  2 3/69 (4.35%)  3
Abdominal Distension  1  1/69 (1.45%)  1 1/66 (1.52%)  1 2/69 (2.90%)  3
Eructation  1  1/69 (1.45%)  1 2/66 (3.03%)  2 1/69 (1.45%)  1
Abdominal Pain Lower  1  0/69 (0.00%)  0 3/66 (4.55%)  3 0/69 (0.00%)  0
Abdominal Pain Upper  1  1/69 (1.45%)  1 4/66 (6.06%)  4 0/69 (0.00%)  0
Abnormal Faeces  1  0/69 (0.00%)  0 2/66 (3.03%)  2 0/69 (0.00%)  0
Frequent Bowel Movements  1  2/69 (2.90%)  2 1/66 (1.52%)  1 0/69 (0.00%)  0
General disorders       
Chills  1  1/69 (1.45%)  1 5/66 (7.58%)  6 5/69 (7.25%)  5
Pain  1  6/69 (8.70%)  7 7/66 (10.61%)  10 5/69 (7.25%)  6
Pyrexia  1  2/69 (2.90%)  2 2/66 (3.03%)  2 5/69 (7.25%)  5
Fatigue  1  0/69 (0.00%)  0 2/66 (3.03%)  3 3/69 (4.35%)  3
Chest Discomfort  1  2/69 (2.90%)  2 1/66 (1.52%)  2 0/69 (0.00%)  0
Oedema Peripheral  1  2/69 (2.90%)  2 0/66 (0.00%)  0 0/69 (0.00%)  0
Infections and infestations       
Upper Respiratory Tract Infection  1  2/69 (2.90%)  2 0/66 (0.00%)  0 3/69 (4.35%)  3
Viral Infection  1  2/69 (2.90%)  2 3/66 (4.55%)  3 1/69 (1.45%)  1
Injury, poisoning and procedural complications       
Muscle Strain  1  0/69 (0.00%)  0 2/66 (3.03%)  2 0/69 (0.00%)  0
Metabolism and nutrition disorders       
Decreased Appetite  1  2/69 (2.90%)  2 4/66 (6.06%)  4 2/69 (2.90%)  2
Musculoskeletal and connective tissue disorders       
Myalgia  1  3/69 (4.35%)  4 7/66 (10.61%)  9 10/69 (14.49%)  13
Arthralgia  1  6/69 (8.70%)  8 2/66 (3.03%)  3 7/69 (10.14%)  11
Pain in Extremity  1  3/69 (4.35%)  5 2/66 (3.03%)  2 5/69 (7.25%)  8
Back Pain  1  8/69 (11.59%)  8 6/66 (9.09%)  6 4/69 (5.80%)  4
Neck Pain  1  2/69 (2.90%)  4 0/66 (0.00%)  0 3/69 (4.35%)  3
Joint Swelling  1  0/69 (0.00%)  0 0/66 (0.00%)  0 2/69 (2.90%)  2
Muscle Spasms  1  3/69 (4.35%)  3 1/66 (1.52%)  1 2/69 (2.90%)  4
Musculoskeletal Pain  1  6/69 (8.70%)  7 3/66 (4.55%)  3 2/69 (2.90%)  3
Nervous system disorders       
Headache  1  20/69 (28.99%)  24 15/66 (22.73%)  27 18/69 (26.09%)  25
Dizziness  1  4/69 (5.80%)  4 4/66 (6.06%)  4 2/69 (2.90%)  2
Psychiatric disorders       
Insomnia  1  0/69 (0.00%)  0 2/66 (3.03%)  2 2/69 (2.90%)  2
Respiratory, thoracic and mediastinal disorders       
Nasal Congestion  1  0/69 (0.00%)  0 2/66 (3.03%)  2 5/69 (7.25%)  5
Cough  1  1/69 (1.45%)  1 2/66 (3.03%)  4 1/69 (1.45%)  1
Oopharyngeal pain  1  2/69 (2.90%)  2 0/66 (0.00%)  0 1/69 (1.45%)  1
Rhinorrhoea  1  2/69 (2.90%)  2 0/66 (0.00%)  0 0/69 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus  1  1/69 (1.45%)  1 2/66 (3.03%)  3 2/69 (2.90%)  2
Vascular disorders       
Flushing  1  0/69 (0.00%)  0 2/66 (3.03%)  2 1/69 (1.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
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: NCT00918749     History of Changes
Other Study ID Numbers: 2009003
First Submitted: June 10, 2009
First Posted: June 11, 2009
Results First Submitted: February 23, 2011
Results First Posted: March 24, 2011
Last Update Posted: June 29, 2015