A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

Summary

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Timeline

Start

2006-05

Primary completion

2009-05

Completion

2009-05

Outcome

Met primary endpoint

registry Ibandronate vs Placebo; p <0.001; Mean Difference (Final Values) 3.25 (95% CI 2.09 to 4.41); ANCOVA NCT00545051 ↗

Drugs

Indications