NCT00325468|CompletedPhase 3Results
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Sponsor study identifier
interventional
200
0 countries
N/A
Study Start
May 1, 2006
Actual (reported)Primary Completion
March 28, 2011
Actual (reported)Study Completion
August 2, 2012
Actual (reported)An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2, 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2006
Actual (reported)May 10, 2006
Actual (reported)May 12, 2006
Actual (reported)March 28, 2011
Actual (reported)August 2, 2012
Actual (reported)July 30, 2013
Actual (reported)Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.
MD
Amgen
200 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2006
First Posted
May 12, 2006
Study Start
May 1, 2006
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 28, 2011
Actual (reported)Study Completion
August 2, 2012
Actual (reported)Last Updated
August 1, 2017
Results First Posted
July 30, 2013
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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