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

Completed · Phase 4

Conditions studied: Post-Menopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT00551174

Run by

Hoffmann-La Roche

People needed

781

Starts

2004-10-01

Expected to finish

2008-11-01

Last updated by the study team

2011-07-22

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
• Ambulatory

You may not qualify if…

• Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study
• Malignant disease diagnosed since inclusion into previous study
• Treatment with drugs affecting bone metabolism since inclusion into previous study

Where it is running

• Study site — Gainesville, Georgia, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Bismarck, North Dakota, United States
• Study site — Fargo, North Dakota, United States
• Study site — Madison, Wisconsin, United States
• Study site — St Leonards, Australia
• Study site — Sydney, Australia
• Study site — Brussels, Belgium
• Study site — Liège, Belgium
• Study site — Pilsen, Czechia
• Study site — Prague, Czechia
• Study site — Aalborg, Denmark
• Study site — Aarhus, Denmark
• Study site — Ballerup Municipality, Denmark
• Study site — Copenhagen, Denmark
• Study site — Vejle, Denmark
• Study site — Lyon, France
• Study site — Orléans, France
• Study site — Berlin, Germany
• Study site — Essen, Germany
• Study site — Hamburg, Germany
• Study site — Budapest, Hungary
• Study site — Arenzano, Italy
• Study site — Siena, Italy

Full record on ClinicalTrials.gov

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