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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
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.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1609 |
| Start date | 2002-04 |
| Completion | 2004-12 |
Conditions
- Post Menopausal Osteoporosis
Interventions
- Ibandronate [Bonviva/Boniva]
- Ibandronate [Bonviva/Boniva]
- Ibandronate [Bonviva/Boniva]
- Ibandronate [Bonviva/Boniva]
- Calcium
- Vitamin D
Primary outcomes
- Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density — From Baseline (Month 0) to Month 12
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
Countries
United States, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, Romania, South Africa, Spain, Switzerland, United Kingdom