Clinical Trial: A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Study Status: No longer available
Recruit Status: No longer available
Study Type: Expanded Access
Official Title: An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.
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 Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome:
Original Primary Outcome: Mean change (%) of spinal BMD at 12 months.
Current Secondary Outcome:
Original Secondary Outcome: Efficacy: Mean change (%) of hip BMD at 12 months, serum CTX at 6 and 12 months, and hip and spinal BMD at 6 months. Safety: AEs, clinical fractures. Satisfaction: Percentage change from baseline in OPSAT-Q at 12 months.
Information By: Hoffmann-La Roche
Dates:
Date Received: June 27, 2007
Date Started: June 2007
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016