At a glance
ClinicalIndex Comparison Record- ✓Women aged 55-80 years
- ✓Postmenopausal for at least 5 years
- ✓Ambulatory
- ✕Malignant disease diagnosed within the previous 10 years (except basal cell cancer successfully removed)
- ✕Breast cancer within the previous 20 years
- ✕Allergy to bisphosphonates
- ✕Previous treatment with intravenous bisphosphonate at any time
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Ibandronate [Bonviva/Boniva], Calcium, and 1 other intervention for Post Menopausal Osteoporosis. Completed, enrolled 1,609 participants across 68 sites in 19 countries.
Detailed Summary
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. 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
2.5mg po daily
100mg po monthly on a single day
100mg po monthly over 2 consecutive days
150mg po monthly
500 mg/day
400 IU/day