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
  Purpose

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.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: AMG 162
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 332
Study Start Date: August 2004
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
Drug: AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
Placebo Comparator: Placebo
Placebo given day 1, month 6, month 12 and month 18
Drug: Placebo
Placebo given at day 1, month 6, month 12 and month 18

  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091793

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00091793     History of Changes
Other Study ID Numbers: 20040132
Study First Received: September 17, 2004
Results First Received: December 22, 2009
Last Updated: December 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Osteoporosis
Postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 23, 2014