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



Status:Completed
Conditions:Osteoporosis, Osteoporosis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:7/15/2017
Start Date:May 2004
End Date:May 2008

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Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549

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.


Inclusion Criteria:

- successful completion of Bonviva study BM16549, with at least 75% compliance;

- ambulatory.

Exclusion Criteria:

- 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.
We found this trial at
6
sites
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Omaha, NE
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Lakewood, CO
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Liege,
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Livingston, NJ
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Loma Linda, CA
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Portland, OR
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