NCT00551174

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 781 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

Conditions

• Post-Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	ibandronate [Bonviva/Boniva]	3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
DRUG	ibandronate [Bonviva/Boniva]	2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-10-30
• Last updated: 2011-07-22
• Results posted: 2011-05-30

Locations

39 sites across 15 countries: United States, Australia, Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, South Africa, Spain, United Kingdom