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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Diphosphonates; Ibandronic Acid

Criteria

Inclusion Criteria:

• successful completion of Bonviva study BM16549, with at least 75% compliance;

• ambulatory.

Exclusion Criteria:

• malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);

• breast cancer diagnosed within the previous 22 years.