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Completed

NCT Number: NCT00091793

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

Up to 90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria

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

Treatment and study plan

AMG 162

Drug

60 mg/mL denosumab given day 1, month 6, month 12 and month 18

Placebo

Drug

Placebo given at day 1, month 6, month 12 and month 18

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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).

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 21, 2004
Registry last updated
Dec 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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