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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00091793 |
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.
Condition | Intervention | Phase |
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Postmenopausal Osteoporosis |
Drug: AMG 162 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis |
Enrollment: | 332 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AMG 162: Experimental
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
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Drug: AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
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Placebo: Placebo Comparator
Placebo given day 1, month 6, month 12 and month 18
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Drug: Placebo
Placebo given at day 1, month 6, month 12 and month 18
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Ages Eligible for Study: | up to 90 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Eligibility Criteria: - Postmenopausal women with Osteopenia (lumbar spine bone mineral density [BMD] T-score between 1.0 and -2.5)
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20040132 |
Study First Received: | September 17, 2004 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00091793 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Osteoporosis Postmenopausal |
Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis Bone Diseases, Metabolic Bone Diseases |