Clinical Trial: Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Brief Summary: 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.

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • 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).


Original Secondary Outcome:

Information By: Amgen

Dates:
Date Received: September 17, 2004
Date Started: August 2004
Date Completion:
Last Updated: December 22, 2010
Last Verified: December 2010