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Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00091793
First Posted: September 21, 2004
Last Update Posted: December 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
September 17, 2004
September 21, 2004
December 22, 2009
January 26, 2010
December 31, 2010
August 2004
February 2009   (Final data collection date for primary outcome measure)
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Not Provided
Complete list of historical versions of study NCT00091793 on ClinicalTrials.gov Archive Site
  • Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
  • Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
  • Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
  • Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]
    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Not Provided
Not Provided
Not Provided
 
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postmenopausal Osteoporosis
  • Drug: AMG 162
    60 mg/mL denosumab given day 1, month 6, month 12 and month 18
  • Drug: Placebo
    Placebo given at day 1, month 6, month 12 and month 18
  • Experimental: AMG 162
    60 mg/mL denosumab given day 1, month 6, month 12 and month 18
    Intervention: Drug: AMG 162
  • Placebo Comparator: Placebo
    Placebo given day 1, month 6, month 12 and month 18
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
March 2009
February 2009   (Final data collection date for primary outcome measure)

Eligibility Criteria

- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Sexes Eligible for Study: Female
up to 90 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   United States
 
NCT00091793
20040132
Not Provided
Not Provided
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP