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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• post-menopausal women, aged 55-75 years;

• diagnosed osteopenia.

Exclusion Criteria:

• history of osteoporotic vertebral fracture;

• contraindication to ibandronate.