Status:
COMPLETED
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Post Menopausal Osteoporosis
Eligibility:
FEMALE
65+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- patients on hormone replacement therapy (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).
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00303485
Start Date
February 1 2006
End Date
June 1 2007
Last Update
May 2 2016
Active Locations (10)
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1
Beverly Hills, California, United States, 90211
2
La Jolla, California, United States, 92093
3
Augusta, Georgia, United States, 30904
4
Woodbury, Minnesota, United States, 55125