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A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

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ClinicalTrials.gov Identifier: NCT00545051
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Postmenopausal Osteoporosis
Interventions Drug: Placebo
Drug: ibandronate
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ibandronate Placebo
Hide Arm/Group Description Participants received 150 milligram (mg) ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 International Units (IU) Vitamin D per day. Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Period Title: Overall Study
Started 68 72
Completed 59 65
Not Completed 9 7
Reason Not Completed
Adverse Event             7             3
Death             1             0
Violation of inclusion/exclusion             0             2
Protocol Violation             1             0
Withdrawal by Subject             0             1
Administrative reasons             0             1
Arm/Group Title Ibandronate Placebo Total
Hide Arm/Group Description Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day. Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day. Total of all reporting groups
Overall Number of Baseline Participants 68 72 140
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population included all participants randomized and who had at least one follow up efficacy data time point available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 72 participants 140 participants
64.4  (7.90) 63.2  (6.83) 63.79  (7.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 72 participants 140 participants
Female
68
 100.0%
72
 100.0%
140
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
Hide Description Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Ibandronate Placebo
Hide Arm/Group Description:
Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Overall Number of Participants Analyzed 66 66
Mean (Standard Deviation)
Unit of Measure: percent change in BMD
3.2  (3.7) -0.1  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.25
Confidence Interval (2-Sided) 95%
2.09 to 4.41
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6
Hide Description Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Ibandronate Placebo
Hide Arm/Group Description:
Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Overall Number of Participants Analyzed 62 66
Mean (Standard Deviation)
Unit of Measure: percent change in BMD
2.6  (3.1) 0.3  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
1.22 to 3.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12
Hide Description Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.
Time Frame Baseline and Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; number (n) equals (=) number of participants analyzed at the specified visit.
Arm/Group Title Ibandronate Placebo
Hide Arm/Group Description:
Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Overall Number of Participants Analyzed 66 66
Mean (Standard Deviation)
Unit of Measure: percent change in BMD
Month 6 (n=62,66) 0.7  (1.9) 0.0  (2.1)
Month 12 (n=66,65) 1.2  (2.2) -0.7  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
-0.15 to 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
0.96 to 2.66
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12
Hide Description Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.
Time Frame Baseline and Months 1, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n=number of participants analyzed at the specified visit for the given parameter.
Arm/Group Title Ibandronate Placebo
Hide Arm/Group Description:
Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: percent change in bone turnover markers
sCTX Month 1 (n=68,68) -44.7  (36.5) -3.8  (33.3)
sCTX Month 6 (n=62,66) -53.3  (24.3) -3.5  (48.0)
sCTX Month 12 (n=65,65) -42.0  (27.9) 11.6  (82.4)
P1NP Month 1 (n=68,68) -23.8  (17.2) -2.3  (22.5)
P1NP Month 6 (n=60,66) -62.5  (16.3) -3.7  (44.5)
P1NP Month 12 (n=64,67) -48.8  (37.2) 12.5  (54.6)
TRACP Month 1 (n=68,68) -31.3  (12.0) -7.3  (11.9)
TRACP Month 6 (n=62,66) -32.9  (14.8) -7.1  (17.0)
TRACP Month 12 (n=65,67) -27.4  (16.5) -6.3  (18.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments sCTX at Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments sCTX at Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments sCTX at Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments P1NP at Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments P1NP at Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments P1NP at Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments TRACP at Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments TRACP at Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibandronate, Placebo
Comments TRACP at Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months
Hide Description Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Ibandronate Placebo
Hide Arm/Group Description:
Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Overall Number of Participants Analyzed 62 66
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0
Time Frame Adverse events were collected from the date of randomization until 15 days after the end of study at 12 months.
Adverse Event Reporting Description The safety population included all participants who had at least one dose of the trial medication, whether withdrawn prematurely or not, and at least one follow-up data point. Two participants received both treatments and were allocated to the ibandronate group for all assessments of safety.
 
Arm/Group Title Ibandronate Placebo
Hide Arm/Group Description Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day. Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
All-Cause Mortality
Ibandronate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ibandronate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/70 (14.29%)   6/70 (8.57%) 
Blood and lymphatic system disorders     
Agranulocytosis * 1  1/70 (1.43%)  0/70 (0.00%) 
Anaemia due to gastrointestinal bleeding * 1  1/70 (1.43%)  0/70 (0.00%) 
Deep vein thrombosis * 1  2/70 (2.86%)  0/70 (0.00%) 
General disorders     
Concussion * 1  1/70 (1.43%)  0/70 (0.00%) 
Infections and infestations     
Acute pancreatitis * 1  1/70 (1.43%)  0/70 (0.00%) 
Erysipelas * 1  0/70 (0.00%)  1/70 (1.43%) 
Pneumonia * 1  0/70 (0.00%)  1/70 (1.43%) 
Acute pyelonephritis * 1  1/70 (1.43%)  0/70 (0.00%) 
Sepsis * 1  1/70 (1.43%)  0/70 (0.00%) 
Injury, poisoning and procedural complications     
Radius fracture * 1  0/70 (0.00%)  1/70 (1.43%) 
Hip fracture * 1  0/70 (0.00%)  1/70 (1.43%) 
Investigations     
Poisoning * 1  1/70 (1.43%)  0/70 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Follicle centre lymphoma * 1  1/70 (1.43%)  0/70 (0.00%) 
Malignant tongue neoplasm * 1  1/70 (1.43%)  0/70 (0.00%) 
Nervous system disorders     
Headache * 1  0/70 (0.00%)  2/70 (2.86%) 
Transient ischaemic attack * 1  1/70 (1.43%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  1/70 (1.43%)  0/70 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibandronate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   19/70 (27.14%)   26/70 (37.14%) 
Gastrointestinal disorders     
Diarrhoea * 1  3/70 (4.29%)  5/70 (7.14%) 
Dyspepsia * 1  0/70 (0.00%)  5/70 (7.14%) 
Nausea * 1  2/70 (2.86%)  4/70 (5.71%) 
Infections and infestations     
Influenza * 1  4/70 (5.71%)  2/70 (2.86%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  8/70 (11.43%)  4/70 (5.71%) 
Back pain * 1  4/70 (5.71%)  4/70 (5.71%) 
Rheumatoid arthritis * 1  4/70 (5.71%)  3/70 (4.29%) 
Nervous system disorders     
Headache * 1  2/70 (2.86%)  7/70 (10.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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 study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmannb-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545051     History of Changes
Other Study ID Numbers: ML20088
First Submitted: October 16, 2007
First Posted: October 17, 2007
Results First Submitted: April 5, 2016
Results First Posted: May 12, 2016
Last Update Posted: May 12, 2016