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| Sponsor: | University of California, San Francisco |
|---|---|
| Collaborator: |
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 sodium Other: placebo comparator |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal |
| Enrollment: | 53 |
| Study Start Date: | February 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: alendronate sodium
alendronate sodium 70 mg tablet once a week for 24 months
|
Drug: alendronate sodium
alendronate sodium 70 mg tablet once week for 24 months
Other Name: fosamax
|
|
Placebo Comparator: placebo
placebo to match alendronate sodium
|
Other: placebo comparator
placebo to match alendronate sodium one tablet once a week for 24 months
Other Name: sugar pill
|
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 | |
| Principal Investigator: | Thomas M Link, MD | University of California, San Francisco |
More Information
| Responsible Party: | Thomas M. Link, MD, UC San Francisco |
| ClinicalTrials.gov Identifier: | NCT00504166 History of Changes |
| Other Study ID Numbers: | M250 |
| Study First Received: | July 17, 2007 |
| Results First Received: | July 13, 2011 |
| Last Updated: | July 13, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Bone Diseases, Metabolic Osteoporosis Bone Diseases Musculoskeletal Diseases |
Alendronate Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |