Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
NCT ID: NCT00091793
Last Updated: 2010-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
332 participants
INTERVENTIONAL
2004-08-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
Placebo
Placebo given day 1, month 6, month 12 and month 18
Placebo
Placebo given at day 1, month 6, month 12 and month 18
Interventions
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AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
Placebo
Placebo given at day 1, month 6, month 12 and month 18
Eligibility Criteria
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Inclusion Criteria
\- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)
90 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Countries
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References
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Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1.
Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. doi: 10.1016/j.bone.2009.03.669. Epub 2009 Apr 2.
Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.
Related Links
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AmgenTrials clinical trials website
Notice regarding posted summaries of trial results
Other Identifiers
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20040132
Identifier Type: -
Identifier Source: org_study_id