drugset / Trial / NCT00129623

A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

NCT00129623 ↗

Phase 4 Completed 160 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Timeline

Start
2005-12
Primary completion
2007-12
Completion
2007-12

Outcome

Met primary endpoint

registry Placebo vs Ibandronate (IBN) 150 mg Monthly; p <0.0001; Mean Difference (Net) 4.1226 (95% CI 2.9613 to 5.2838) NCT00129623 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibandronate Other / unclassified 150 mg Oral