Trial · NCT00545363
A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
NCT00545363, Phase 4, Completed, Hoffmann-La Roche; results first posted 2016-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP). Trials, record NCT00545363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00545363
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
- NCT number
- NCT00545363
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 716 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Ibandronate
- First posted
- 2007-10-17
- Last updated
- 2016-10-24
- Other registries' IDs
- eudract:2005-005529-74
- Results first posted
- 2016-10-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adherence to Treatment | Up to 6 months | Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively. |
| Secondary | Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores | At Month 6 | The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score. |
| Secondary | Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score | At Month 6 | OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. |
| Secondary | Percent Change From Baseline in CTX Based on Adherence to Ibandronate | Baseline, Month 6 | Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on CRF and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adherence to Treatment | Up to 6 months | Intent to treat (ITT) population included all randomized participants. Number of participants analyzed=number of participants evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores | At Month 6 | ITT population. Number of participants analyzed = participants evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score | At Month 6 | ITT population. Number of participants analyzed = participants evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in CTX Based on Adherence to Ibandronate | Baseline, Month 6 | ITT population. Number of participants analyzed = participants evaluable for this outcome and n represents number of participants analyzed for the specified category. | percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adherence to Treatment | BMF Participants | 98.5 | percentage of participants | ||
| Percentage of Participants With Adherence to Treatment | No BMF Participants | 98.6 | percentage of participants | ||
| Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores | BMF Participants | 87.72 | percentage of participants | ||
| Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores | No BMF Participants | 87.62 | percentage of participants | ||
| Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score | BMF Participants | 74.9 | percentage of participants | ||
| Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score | No BMF Participants | 72.2 | percentage of participants | ||
| Percent Change From Baseline in CTX Based on Adherence to Ibandronate | BMF Participants | Adherence-Yes (n=279, 281) | -47.5 | 95% Confidence Interval -51.3 to -43.5 | percent change |
| Percent Change From Baseline in CTX Based on Adherence to Ibandronate | No BMF Participants | Adherence-Yes (n=279, 281) | -47.5 | 95% Confidence Interval -51.0 to -43.9 | percent change |
| Percent Change From Baseline in CTX Based on Adherence to Ibandronate | BMF Participants | Adherence-No (n=1, 6) | -71.74 | 95% Confidence Interval NA to NA | percent change |
| Percent Change From Baseline in CTX Based on Adherence to Ibandronate | No BMF Participants | Adherence-No (n=1, 6) | -25.8 | 95% Confidence Interval -91.0 to 13.5 | percent change |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bone Marker Feedback (BMF) Participants | 358 | |
| Overall Study | STARTED | No BMF Participants | 358 | |
| Overall Study | Treated | Bone Marker Feedback (BMF) Participants | 354 | |
| Overall Study | Treated | No BMF Participants | 357 | |
| Overall Study | COMPLETED | Bone Marker Feedback (BMF) Participants | 339 | |
| Overall Study | COMPLETED | No BMF Participants | 343 | |
| Overall Study | NOT COMPLETED | Bone Marker Feedback (BMF) Participants | 19 | |
| Overall Study | NOT COMPLETED | No BMF Participants | 15 |
Source ClinicalTrials.gov
Adverse events338
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 |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | BMF Participants | 0 | 354 | |
| other | Anaemia | Blood and lymphatic system disorders | No BMF Participants | 2 | 357 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | BMF Participants | 1 | 354 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | No BMF Participants | 0 | 357 | |
| other | Palpitations | Cardiac disorders | BMF Participants | 1 | 354 | |
| other | Palpitations | Cardiac disorders | No BMF Participants | 0 | 357 | |
| other | Tachycardia | Cardiac disorders | BMF Participants | 3 | 354 | |
| other | Tachycardia | Cardiac disorders | No BMF Participants | 0 | 357 | |
| other | Tricuspid valve disease | Cardiac disorders | BMF Participants | 1 | 354 | |
| other | Tricuspid valve disease | Cardiac disorders | No BMF Participants | 0 | 357 |
1 to 10 of 338Source ClinicalTrials.gov
See all 338 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMF Participants | ||
| Total, all-cause mortality | No BMF Participants | ||
| Total, other adverse events | BMF Participants | 196 | 354 |
| Total, other adverse events | No BMF Participants | 224 | 357 |
| Total, serious adverse events | BMF Participants | 8 | 354 |
| Total, serious adverse events | No BMF Participants | 5 | 357 |
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 |
|---|
| BMF Participants vs No BMF Participants: 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/NCT00545363
GET https://conductscience.org/api/trials/v1/NCT00545363/events?page=2