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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

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

Criteria

Inclusion Criteria:

• women 45-60 years of age;

• post-menopausal;

• ambulatory.

Exclusion Criteria:

• vertebral fracture (except traumatic fracture such as in a motor vehicle accident);

• low-trauma osteoporotic fracture in any other bone;

• breast cancer diagnosed within last 20 years;

• other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;

• treatment with any bisphosphonate within last 2 years;

• treatment with other drugs affecting bone metabolism within last 6 months.