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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00092014 |
This study is to evaluate and compare the effects of two approved medications to treat women with postmenopausal osteoporosis.
Condition | Intervention | Phase |
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Postmenopausal Osteoporosis |
Drug: MK0217, alendronate sodium/Duration of Treatment: 12 mo Drug: Comparator: risedronate/Duration of Treatment: 12 mo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Once Weekly Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis |
Estimated Enrollment: | 900 |
Study Start Date: | February 2002 |
Ages Eligible for Study: | 25 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: | 2004_016, MK0217-211 |
Study First Received: | September 21, 2004 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00092014 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Musculoskeletal Diseases Alendronate Osteoporosis, Postmenopausal Calcium Channel Blockers Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Cardiovascular Agents Bone Diseases Risedronic acid |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Osteoporosis Calcium Channel Blockers Bone Diseases, Metabolic Bone Density Conservation Agents Cardiovascular Agents Bone Diseases |
Pharmacologic Actions Membrane Transport Modulators Musculoskeletal Diseases Alendronate Therapeutic Uses Osteoporosis, Postmenopausal Risedronic acid |