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| Sponsors and Collaborators: |
University of California, San Francisco Merck |
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00504166 |
Purpose
The purpose of this study is to evaluate the changes in bone structure as determined by magnetic resonance imaging measurements among early postmenopausal women after 24 months of treatment with alendronate, 70 mg once a week as compared to placebo
| Condition | Intervention | Phase |
|
Osteopenia Osteoporosis |
Drug: alendronate |
Phase IV |
| MedlinePlus related topics: | Osteoporosis |
| ChemIDplus related topics: | Alendronate Alendronate sodium |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal |
| Enrollment: | 44 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
This is a randomized, double-blind, 24-month study. Fifty-five postmenopausal women, age range of 45-65 years, with low bone density will be recruited, with half of the subjects receiving alendronate + 2800 IU of vitamin D once weekly, the other half receiving placebo + 2800 IU of vitamin D once weekly. All study subjects will receive supplemental calcium 1000 mg/day + Vitamin D 400 IU/day. Measurements of microarchitecture will be made in the wrist, ankle, and hip, and the changes in trabecular bone will be assessed at 0, 12 and 24 months. Markers of bone turnover and bone mineral density (BMD) will be used to characterize the cohort and postmenopausal changes in bone turnover and density.
Eligibility
| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| University of California Department of Radiology | |||||
| San Francisco, California, United States, 94107 | |||||
| University of California, San Francisco |
| Merck |
| Principal Investigator: | Thomas M Link, MD | University of California, San Francisco |
More Information
| Responsible Party: | UC San Francisco ( Thomas M. Link, MD ) |
| Study ID Numbers: | M250 |
| First Received: | July 17, 2007 |
| Last Updated: | May 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00504166 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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