A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

• Status: No longer available
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• post-menopausal women with osteoporosis;

• <=80 years of age;

• naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year.

Exclusion Criteria:

• metabolic bone disease other than post-menopausal osteoporosis;

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

• previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).