drugset / Trial / NCT00551174
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.
Timeline
- Start
- 2004-10
- Primary completion
- 2008-11
- Completion
- 2008-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ibandronate | Other / unclassified | 2 mg | Intravenous |
| Comparator | Ibandronate | Other / unclassified | 3 mg | Intravenous |