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Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00091793
First received: September 17, 2004
Last updated: December 22, 2010
Last verified: December 2010

September 17, 2004
December 22, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Female
up to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00091793
20040132
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