At a glance
ClinicalIndex Comparison Record- ✓Successful completion of prior Bonviva study BM16549 with at least 75% compliance
- ✓Ambulatory status
- ✕Malignant disease diagnosed within the previous 12 years (except successfully removed basal cell cancer)
- ✕Breast cancer diagnosed within the previous 22 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549
In Brief
A Phase 4 clinical trial evaluating ibandronate [Bonviva/Boniva] for Post-Menopausal Osteoporosis. Completed, enrolled 719 participants across 31 sites in 14 countries.
Detailed Summary
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Study Details
Timeline
Interventions
150mg po monthly for 3 years
100mg po monthly for 3 years