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A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

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ClinicalTrials.gov Identifier: NCT00377234
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : July 22, 2015
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Post Menopausal Osteoporosis
Interventions Drug: Risedronate
Drug: ibandronate [Bonviva/Boniva]
Enrollment 356
Recruitment Details Of the 488 patients who were screened, 356 patients were enrolled into the study at 44 centers in the USA and randomized to treatment with ibandronate and risedronate. One hundred eighty patients were randomized to Sequence A (Period 1 ibandronate, Period 2 risedronate), and 176 patients to Sequence B (Period 1 risedronate, Period 2 ibandronate).
Pre-assignment Details  
Arm/Group Title Sequence A Sequence B
Hide Arm/Group Description Ibandronate followed by risedronate Risedronate followed by ibandronate
Period Title: Overall Study
Started 180 176
Randomized 180 176
Did Not Receive Study Treatment 3 2
Received Treatment 177 174
Safety Analysis Set: Period 1 177 174
Safety Analysis Set: Period 2 153 150
Safety Analysis Set: Ibandronate 177 150
Safety Analysis Set: Risedronate 153 174
Completed 146 145
Not Completed 34 31
Reason Not Completed
Adverse Event             14             17
Withdrawal by Subject             11             9
Lost to Follow-up             4             2
Administrative             2             1
Not assigned             3             2
Arm/Group Title Sequence A Sequence B Total
Hide Arm/Group Description Ibandronate followed by risedronate Risedronate followed by ibandronate Total of all reporting groups
Overall Number of Baseline Participants 177 174 351
Hide Baseline Analysis Population Description
Safety Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 177 participants 174 participants 351 participants
64.6  (7.0) 64.0  (6.7) 64.3  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 174 participants 351 participants
Female
177
 100.0%
174
 100.0%
351
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 177 participants 174 participants 351 participants
177 174 351
1.Primary Outcome
Title Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing
Time Frame at 6 months
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Hide Analysis Population Description
Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment
Arm/Group Title During Sequence A During Sequence B Total
Hide Arm/Group Description:
Ibandronate followed by risedronate
Risendronate followed by ibandronate
During period 1 + during period 2
Overall Number of Participants Analyzed 131 147 278
Measure Type: Number
Unit of Measure: percentage of participants
81.7 78.2 79.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. Null hypothesis is rejected if P-value was below significance threshold of P <0.05
Method Garts Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested.
Method Prescott Test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate
Time Frame within 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment
Arm/Group Title During Sequence A During Sequence B Total
Hide Arm/Group Description:
Ibandronate followed by risedronate
Risedronate followed by ibandronate
During period 1 + during period 2
Overall Number of Participants Analyzed 131 131 262
Measure Type: Number
Unit of Measure: percentage of participants
85.5 87.0 86.3
3.Secondary Outcome
Title Intensity of Upper Gastrointestinal (GI) Symptoms
Hide Description Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.
Time Frame within 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Ibandronate Risedronate
Hide Arm/Group Description:
While being treated with ibandronate
While being treated with risendronate
Overall Number of Participants Analyzed 177 174
Measure Type: Number
Unit of Measure: percentage of participants
Any 46.1 56.5
Mild 41.3 49.1
Moderate 32.3 36.0
Severe 15.6 12.4
4.Secondary Outcome
Title Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)
Hide Description During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.
Arm/Group Title Sequence A Sequence B
Hide Arm/Group Description:
ibandronate followed by risedronate
risedronate followed by ibandronate
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)
Hide Description During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.
Arm/Group Title Sequence A Sequence B
Hide Arm/Group Description:
ibandronate followed by risedronate
risedronate followed by ibandronate
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Study duration was approximately 6 months (3 months and 12 weeks) and a follow-up period of 15 days after the completion of treatment was included to assess safety information. Participants were assessed for adverse events for a total of 6.5 months.
Adverse Event Reporting Description The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
 
Arm/Group Title Ibandronate Risedronate
Hide Arm/Group Description Ibandronate adverse events Risendronate adverse events
All-Cause Mortality
Ibandronate Risedronate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ibandronate Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/327 (1.53%)      3/327 (0.92%)    
Cardiac disorders     
Coronary Artery Disease  1  1/327 (0.31%)  1 0/327 (0.00%)  0
Pericarditis  1  1/327 (0.31%)  1 0/327 (0.00%)  0
Eye disorders     
Vitreous Haemorrhage  1  0/327 (0.00%)  0 1/327 (0.31%)  1
Gastrointestinal disorders     
Abdominal Hernia  1  1/327 (0.31%)  1 0/327 (0.00%)  0
Small Intestinal Obstruction  1  1/327 (0.31%)  1 0/327 (0.00%)  0
Umbilical Hernia  1  1/327 (0.31%)  1 0/327 (0.00%)  0
Infections and infestations     
Bronchitis  1  0/327 (0.00%)  0 1/327 (0.31%)  1
Injury, poisoning and procedural complications     
Post Procedural Haemorrhage  1  1/327 (0.31%)  1 0/327 (0.00%)  0
Reproductive system and breast disorders     
Ovarian Cyst  1  1/327 (0.31%)  1 0/327 (0.00%)  0
Vascular disorders     
Malignant Hypertension  1  0/327 (0.00%)  0 1/327 (0.31%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibandronate Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/327 (0.00%)      0/327 (0.00%)    
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 only after the first publication or presentation that involves the Overall Study. The 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: Hoffmann-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377234     History of Changes
Other Study ID Numbers: MA19547
First Submitted: September 15, 2006
First Posted: September 18, 2006
Results First Submitted: June 25, 2015
Results First Posted: July 22, 2015
Last Update Posted: August 1, 2016