A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Completed · Phase 4

Conditions studied: Post-Menopausal Osteoporosis

In brief

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00081653

Run by

Hoffmann-La Roche

People needed

719

Starts

2004-05-01

Expected to finish

2008-05-01

Last updated by the study team

2017-07-14

Who can join

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

You may qualify if…

• successful completion of Bonviva study BM16549, with at least 75% compliance;
• ambulatory.

You may not qualify if…

• malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
• breast cancer diagnosed within the previous 22 years.

Where it is running

• Study site — Loma Linda, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Omaha, Nebraska, United States
• Study site — Livingston, New Jersey, United States
• Study site — Portland, Oregon, United States
• Study site — Liège, Belgium
• Study site — Merksem, Belgium
• Study site — São Paulo, Brazil
• Study site — Pilsen, Czechia
• Study site — Prague, Czechia
• Study site — Aalborg, Denmark
• Study site — Ballerup Municipality, Denmark
• Study site — Vejle, Denmark
• Study site — Lyon, France
• Study site — Berlin, Germany
• Study site — Hanover, Germany
• Study site — Balatonfüred, Hungary
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary
• Study site — Kiskunhalas, Hungary
• Study site — Zalaegerszeg, Hungary
• Study site — Siena, Italy
• Study site — León, Mexico
• Study site — Obregón, Mexico
• Study site — Haugesund, Norway

Full record on ClinicalTrials.gov

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