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 |
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.
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).
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