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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00389740 |
The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.
Condition | Intervention | Phase |
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Osteoporosis, Postmenopausal |
Drug: MK0217, /Duration of Treatment : 12 Months Drug: Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Raloxifene on Bone Mineral Density in Postmenopausal Women With Osteoporosis |
Enrollment: | 400 |
Study Start Date: | February 2001 |
Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2006_537 |
Study First Received: | October 18, 2006 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00389740 |
Health Authority: | United States: Food and Drug Administration |
Raloxifene Musculoskeletal Diseases Alendronate Osteoporosis, Postmenopausal |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Estrogen Receptor Modulators Estrogen Antagonists Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions |