Trial · NCT00377234
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
NCT00377234, Phase 4, Completed, Hoffmann-La Roche; results first posted 2015-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis. Trials, record NCT00377234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00377234
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
- NCT number
- NCT00377234
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 356 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Post Menopausal Osteoporosis
- Interventions
- Risedronate, ibandronate [Bonviva/Boniva]
- First posted
- 2006-09-18
- Last updated
- 2016-08-01
- Results first posted
- 2015-07-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing | at 6 months | 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. |
| Secondary | Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate | within 6 months | 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. |
| Secondary | Intensity of Upper Gastrointestinal (GI) Symptoms | within 3 months | 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. |
| Secondary | 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) | 3 months | 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. |
| Secondary | 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) | 3 months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing | at 6 months | Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate | within 6 months | mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment | percentage of participants | NUMBER |
| SECONDARY | Intensity of Upper Gastrointestinal (GI) Symptoms | within 3 months | Safety analysis set | percentage of participants | NUMBER |
| SECONDARY | 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) | 3 months | 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. | ||
| SECONDARY | 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) | 3 months | 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. |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing | During Sequence A | 81.7 | percentage of participants | ||
| Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing | During Sequence B | 78.2 | percentage of participants | ||
| Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing | Total | 79.9 | percentage of participants | ||
| Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate | During Sequence A | 85.5 | percentage of participants | ||
| Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate | During Sequence B | 87.0 | percentage of participants | ||
| Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate | Total | 86.3 | percentage of participants | ||
| Intensity of Upper Gastrointestinal (GI) Symptoms | Ibandronate | Any | 46.1 | percentage of participants | |
| Intensity of Upper Gastrointestinal (GI) Symptoms | Risedronate | Any | 56.5 | percentage of participants | |
| Intensity of Upper Gastrointestinal (GI) Symptoms | Ibandronate | Mild | 41.3 | percentage of participants | |
| Intensity of Upper Gastrointestinal (GI) Symptoms | Risedronate | Mild | 49.1 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence A | 180 | |
| Overall Study | STARTED | Sequence B | 176 | |
| Overall Study | Randomized | Sequence A | 180 | |
| Overall Study | Randomized | Sequence B | 176 | |
| Overall Study | Did Not Receive Study Treatment | Sequence A | 3 | |
| Overall Study | Did Not Receive Study Treatment | Sequence B | 2 | |
| Overall Study | Received Treatment | Sequence A | 177 | |
| Overall Study | Received Treatment | Sequence B | 174 | |
| Overall Study | Safety Analysis Set: Period 1 | Sequence A | 177 | |
| Overall Study | Safety Analysis Set: Period 1 | Sequence B | 174 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Coronary Artery Disease | Cardiac disorders | Ibandronate | 1 | 327 | 1 |
| serious | Coronary Artery Disease | Cardiac disorders | Risedronate | 0 | 327 | 0 |
| serious | Pericarditis | Cardiac disorders | Ibandronate | 1 | 327 | 1 |
| serious | Pericarditis | Cardiac disorders | Risedronate | 0 | 327 | 0 |
| serious | Vitreous Haemorrhage | Eye disorders | Ibandronate | 0 | 327 | 0 |
| serious | Vitreous Haemorrhage | Eye disorders | Risedronate | 1 | 327 | 1 |
| serious | Abdominal Hernia | Gastrointestinal disorders | Ibandronate | 1 | 327 | 1 |
| serious | Abdominal Hernia | Gastrointestinal disorders | Risedronate | 0 | 327 | 0 |
| serious | Small Intestinal Obstruction | Gastrointestinal disorders | Ibandronate | 1 | 327 | 1 |
| serious | Small Intestinal Obstruction | Gastrointestinal disorders | Risedronate | 0 | 327 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibandronate | ||
| Total, all-cause mortality | Risedronate | ||
| Total, other adverse events | Ibandronate | 0 | 327 |
| Total, other adverse events | Risedronate | 0 | 327 |
| Total, serious adverse events | Ibandronate | 5 | 327 |
| Total, serious adverse events | Risedronate | 3 | 327 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ibandronate vs Risedronate: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00377234
GET https://conductscience.org/api/trials/v1/NCT00377234/registered