Trial Outcomes & Findings for A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis. (NCT NCT00377234)
NCT ID: NCT00377234
Last Updated: 2016-08-01
Results Overview
Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.
COMPLETED
PHASE4
356 participants
at 6 months
2016-08-01
Participant Flow
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).
Participant milestones
| Measure |
Sequence A
Ibandronate followed by risedronate
|
Sequence B
Risedronate followed by ibandronate
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
176
|
|
Overall Study
Randomized
|
180
|
176
|
|
Overall Study
Did Not Receive Study Treatment
|
3
|
2
|
|
Overall Study
Received Treatment
|
177
|
174
|
|
Overall Study
Safety Analysis Set: Period 1
|
177
|
174
|
|
Overall Study
Safety Analysis Set: Period 2
|
153
|
150
|
|
Overall Study
Safety Analysis Set: Ibandronate
|
177
|
150
|
|
Overall Study
Safety Analysis Set: Risedronate
|
153
|
174
|
|
Overall Study
COMPLETED
|
146
|
145
|
|
Overall Study
NOT COMPLETED
|
34
|
31
|
Reasons for withdrawal
| Measure |
Sequence A
Ibandronate followed by risedronate
|
Sequence B
Risedronate followed by ibandronate
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
17
|
|
Overall Study
Withdrawal by Subject
|
11
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Administrative
|
2
|
1
|
|
Overall Study
Not assigned
|
3
|
2
|
Baseline Characteristics
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Baseline characteristics by cohort
| Measure |
Sequence A
n=177 Participants
Ibandronate followed by risedronate
|
Sequence B
n=174 Participants
Risedronate followed by ibandronate
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
64.0 Years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
64.3 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
177 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
177 participants
n=5 Participants
|
174 participants
n=7 Participants
|
351 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6 monthsPopulation: Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment
Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.
Outcome measures
| Measure |
During Sequence A
n=131 Participants
Ibandronate followed by risedronate
|
During Sequence B
n=147 Participants
Risendronate followed by ibandronate
|
Total
n=278 Participants
During period 1 + during period 2
|
|---|---|---|---|
|
Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing
|
81.7 percentage of participants
|
78.2 percentage of participants
|
79.9 percentage of participants
|
SECONDARY outcome
Timeframe: within 6 monthsPopulation: mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment
Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.
Outcome measures
| Measure |
During Sequence A
n=131 Participants
Ibandronate followed by risedronate
|
During Sequence B
n=131 Participants
Risendronate followed by ibandronate
|
Total
n=262 Participants
During period 1 + during period 2
|
|---|---|---|---|
|
Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate
|
85.5 percentage of participants
|
87.0 percentage of participants
|
86.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 3 monthsPopulation: Safety analysis set
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.
Outcome measures
| Measure |
During Sequence A
n=177 Participants
Ibandronate followed by risedronate
|
During Sequence B
n=174 Participants
Risendronate followed by ibandronate
|
Total
During period 1 + during period 2
|
|---|---|---|---|
|
Intensity of Upper Gastrointestinal (GI) Symptoms
Severe
|
15.6 percentage of participants
|
12.4 percentage of participants
|
—
|
|
Intensity of Upper Gastrointestinal (GI) Symptoms
Any
|
46.1 percentage of participants
|
56.5 percentage of participants
|
—
|
|
Intensity of Upper Gastrointestinal (GI) Symptoms
Mild
|
41.3 percentage of participants
|
49.1 percentage of participants
|
—
|
|
Intensity of Upper Gastrointestinal (GI) Symptoms
Moderate
|
32.3 percentage of participants
|
36.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Ibandronate
Risedronate
Serious adverse events
| Measure |
Ibandronate
n=327 participants at risk
Ibandronate adverse events
|
Risedronate
n=327 participants at risk
Risendronate adverse events
|
|---|---|---|
|
Cardiac disorders
Coronary Artery Disease
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Cardiac disorders
Pericarditis
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
|
Vascular disorders
Malignant Hypertension
|
0.00%
0/327 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
0.31%
1/327 • Number of events 1 • 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.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Medical Communications
Hoffmann-LaRoche
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER