Trial · NCT00545779
BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
NCT00545779, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy. Trials, record NCT00545779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00545779
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
- NCT number
- NCT00545779
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 677 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Post-Menopausal Osteoporosis
- Interventions
- Ibandronate
- First posted
- 2007-10-17
- Last updated
- 2016-10-28
- Results first posted
- 2016-10-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ) | Visit 0 (less than or equal to [<=] Day -30) | The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule. 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication. 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication. |
| Primary | Percentage of Participants Who Reported Preference for Monthly Ibandronate | Visit 0 (<= Day -30) | Percentage of participants who reported preference for monthly ibandronate were reported. |
| Primary | Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Month 6 | Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction. |
| Secondary | Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ | Visit 0 (<= Day -30) | |
| Secondary | Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | Month 6 | Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication |
| Secondary | Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B | Up to Month 6 | |
| Secondary | Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B | Visit 0 (<= Day -30) | |
| Secondary | Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B | Baseline to Month 6 | |
| Secondary | Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B | Month 6 | |
| Secondary | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Baseline, 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). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ) | Visit 0 (less than or equal to [<=] Day -30) | All enrolled participants who completed the part A of the study. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Reported Preference for Monthly Ibandronate | Visit 0 (<= Day -30) | All enrolled participants who completed the part A of the study. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Month 6 | The intent-to treat (ITT) population included all participants who received at least one dose of study medication. Number of participant analyzed are with or without previous history of Fr. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ | Visit 0 (<= Day -30) | The ITT population included all participants who received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | Month 6 | The ITT population included all participants who received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B | Up to Month 6 | The ITT population included all participants who received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B | Visit 0 (<= Day -30) | The ITT population included all participants who received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B | Baseline to Month 6 | Analysis was not performed because the data were difficult or impossible to derive from the database. | ||
| SECONDARY | Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B | Month 6 | Analysis was not performed because the data were difficult or impossible to derive from the database. | ||
| SECONDARY | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Baseline, Month 6 | The ITT population included all participants who received at least one dose of study medication. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ) | Ibandronate | 68.1 | percentage of participants | ||
| Percentage of Participants Who Reported Preference for Monthly Ibandronate | Ibandronate | 67.5 | percentage of participants | ||
| Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Ibandronate | Participants answer Yes with previous Fr (n=115) | 86.1 | percentage of participants | |
| Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Ibandronate | Participants answer Yes without previous Fr(n=310) | 89.0 | percentage of participants | |
| Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Ibandronate | Participants answer NO with previous Fr (n=47) | 87.2 | percentage of participants | |
| Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Ibandronate | Participants answer NO without previous Fr (n=155) | 77.4 | percentage of participants | |
| Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ | Ibandronate | Answered Yes to at least 1 question in CIQ | 68.1 | percentage of participants | |
| Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ | Ibandronate | Answered NO to every question in CIQ | 31.9 | percentage of participants | |
| Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | Ibandronate | CIQ Question 1 = Yes (n=422) | 88.2 | percentage of participants | |
| Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | Ibandronate | CIQ Question 1 = No (n=205) | 80.0 | percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibandronate | 677 | |
| Overall Study | COMPLETED | Ibandronate | 633 | |
| Overall Study | NOT COMPLETED | Ibandronate | 44 |
Source ClinicalTrials.gov
Adverse events11
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 | Dyspepsia | Gastrointestinal disorders | Ibandronate | 12 | 640 | |
| other | Nausea | Gastrointestinal disorders | Ibandronate | 7 | 640 | |
| serious | Pericarditis | Cardiac disorders | Ibandronate | 1 | 640 | |
| serious | Iridocyclitis | Eye disorders | Ibandronate | 1 | 640 | |
| serious | Abdominal pain upper | Gastrointestinal disorders | Ibandronate | 1 | 640 | |
| serious | Hiatus hernia | Gastrointestinal disorders | Ibandronate | 1 | 640 | |
| serious | Pyrexia | General disorders | Ibandronate | 1 | 640 | |
| serious | Postoperative hernia | Injury, poisoning and procedural complications | Ibandronate | 1 | 640 | |
| serious | Bone pain | Musculoskeletal and connective tissue disorders | Ibandronate | 1 | 640 | |
| serious | Renal failure acute | Renal and urinary disorders | Ibandronate | 1 | 640 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibandronate | ||
| Total, other adverse events | Ibandronate | 18 | 640 |
| Total, serious adverse events | Ibandronate | 6 | 640 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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