drugset / Trial / NCT00081653

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

NCT00081653

Phase 4 Completed 719 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2004-05
Primary completion
2007-11
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibandronate Other / unclassified 100 mg Oral
Comparator Ibandronate Other / unclassified 150 mg Oral