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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00398931 |
This study was conducted among women who had previously received alendronate for 3 to 6 years during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly assigned to receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5 years, in order to evaluate the effects of continuing or discontinuing alendronate treatment on bone mineral density and biochemical markers of bone turnover.
Condition | Intervention | Phase |
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Osteoporosis, Postmenopausal |
Drug: MK0217, alendronate sodium / Duration of Treatment : 5 Years Drug: Comparator : placebo (unspecified) /Duration of Treatment : 5 Years |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A 5-Year, Double-Blind, Randomized, Placebo-Controlled Extension Study to Examine the Long-Term Safety and Efficacy of Oral Alendronate in Postmenopausal Women Who Previously Received Alendronate in Conjunction With the Fracture Intervention Trial |
Ages Eligible for Study: | 60 Years to 86 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2006_558, MK0217-051 |
Study First Received: | November 10, 2006 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00398931 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Musculoskeletal Diseases Alendronate Fractures, Bone Osteoporosis, Postmenopausal |
Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Alendronate Physiological Effects of Drugs Osteoporosis, Postmenopausal Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |