Phase 3
Completed N=677
BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
Post-Menopausal Osteoporosis
Source: ClinicalTrials.gov NCT00545779 ↗
Enrolled (actual)
677
Serious AEs
0.9%
Results posted
Oct 2016
Primary outcomePrimary: 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) — 68.1 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
68.1 | — |
| PRIMARY Percentage of Participants Who Reported Preference for Monthly Ibandronate |
67.5 | — |
| PRIMARY Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group |
86.1; 89.0; 87.2; 77.4 | — |
| SECONDARY Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ |
68.1; 31.9 | — |
| SECONDARY Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B |
88.2; 80.0; 93.0; 83.8; 94.8; 83.8 | — |
| SECONDARY Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B |
98.6 | — |
| SECONDARY Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B |
99.4 | — |
| SECONDARY Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B |
— | — |
| SECONDARY Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B |
— | — |
| SECONDARY Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B |
58.4; 89.2; 62.6; 86.6; 61.4; 89.1 | — |
Eligibility Criteria
Inclusion Criteria
- post-menopausal women;
- >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.
Exclusion Criteria
- inability to stand or sit in an upright position for at least 60 minutes;
- hypersensitivity to bisphosphonates;
- treatment with other drugs affecting bone metabolism;
- abnormalities of the oesophagus, which delay oesophageal emptying.
Data sourced from ClinicalTrials.gov (NCT00545779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.