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

• Conditions: Postmenopausal Osteoporosis

• Registration Number: NCT00493532
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Study First Posted: 2007-06-28
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Female
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified