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Completed

NCT Number: NCT00089674

AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Other criteria also apply

Treatment and study plan

AMG 162

Drug

60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

Placebo

Drug

60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

Primary outcomes

  1. Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24

    Time frame: 24 months

    Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

Secondary outcomes

  1. Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24

    Time frame: 24 months

    Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

  2. Total Hip Bone Mineral Density Percent Change From Baseline at Month 24

    Time frame: 24 months

    Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

  3. Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36

    Time frame: 36 months

    Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

  4. Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36

    Time frame: 36 months

    Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

  5. Total Hip Bone Mineral Density Percent Change From Baseline at Month 36

    Time frame: 36 months

    Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

  6. Number of Participants With Any Fracture Through Month 36

    Time frame: 36 months

    Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.

  7. Number of Participants With a New Vertebral Fracture Through Month 36

    Time frame: 36 months

    New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture.

  8. Time to First Clinical Fracture Through Month 36

    Time frame: 36 months

    A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture.

  9. Number of Participants With Any Fracture Through Month 24

    Time frame: 24 months

    Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

Important dates

Study start
2004
Primary completion
2008
Study completion
2010
First posted
Aug 11, 2004
Registry last updated
Oct 17, 2018

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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