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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00330460 |
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.
Condition | Intervention | Phase |
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Osteoporosis Osteopenia |
Drug: Alendronate Drug: Denosumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Denisty |
Enrollment: | 1189 |
Study Start Date: | May 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Alendronate: Active Comparator
Subjects in this arm will receive active ALN and placebo denosumab
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Drug: Alendronate
ALN; 70 mg; oral; once weekly
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Denosumab: Experimental
Subjects in this arm will receive active denosumab and placbo ALN
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Drug: Denosumab
60 mg; SC; every 6 months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Patient is an ambulatory postmenopausal woman - Patient has BMD value that corresponds to a T-score of less than or equal to -2.0 (g/cm2) at the lumbar spine OR total hip within range specific to the study protocol. Exclusion Criteria: o Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Evidence of any of the following per subject report, chart review or central laboratory result:
Hyper- or hypothyroidism; however, subjects on stable thyroid hormone replacement therapy may be allowed per the following criteria:
Elevated transaminases
Contraindicated or poorly tolerant of ALN therapy; contraindications for ALN therapy include:
Oral bisphosphonate treatment:
Administration of any of the following treatments within 3 months of randomization:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050141 |
Study First Received: | April 6, 2006 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00330460 |
Health Authority: | United States: Food and Drug Administration |
Osteoporosis Osteopenia AMG 162 Fracture - hip Postmenopausal |
Musculoskeletal Diseases Alendronate Fractures, Bone |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |