A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)



Status:Completed
Conditions:Osteoporosis, Osteoporosis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:65 - Any
Updated:4/21/2016
Start Date:February 2006
End Date:July 2007

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A Randomized Double-blind Study to Determine the Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once-monthly Boniva (Ibandronate) Versus Placebo in the Treatment of Post-menopausal Osteoporosis

This study will determine the rapidity of suppression of the bone resorption marker sCTX in
post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated.
Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with
vitamin D and calcium supplementation. The anticipated time on study treatment is 3-12
months, and the target sample size is <100 individuals.


Inclusion Criteria:

- women who have been newly diagnosed with post-menopausal osteoporosis, requiring
treatment;

- naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3
months, at least 5 years before screening.

Exclusion Criteria:

- patients on HRT within the last 3 months;

- patients on other osteoporosis medication within the last 3 months;

- sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal
level;

- hypersensitivity to any component of ibandronate;

- contraindication for calcium or vitamin D therapy;

- history of major gastrointestinal upset;

- malignant disease diagnosed within the previous 10 years (except resected basal cell
cancer).
We found this trial at
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Madison, WI
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Augusta, GA
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Beverly Hills, California 90211
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La Jolla, CA
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Ponce,
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Woodbury, MN
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