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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00089674
First received: August 9, 2004
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
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: Treatment
Official 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

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


Secondary Outcome Measures:
  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

  • Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

  • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

  • Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

  • Number of Participants With Any Fracture Through Month 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.

  • Number of Participants With a New Vertebral Fracture Through Month 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.

  • Time to First Clinical Fracture Through Month 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Any Fracture Through Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.


Enrollment: 1468
Study Start Date: August 2004
Study Completion Date: July 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 162 Drug: AMG 162
60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
Placebo Comparator: Placebo Drug: Placebo
60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Other criteria also apply

  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: NCT00089674

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: Amgen
ClinicalTrials.gov Identifier: NCT00089674     History of Changes
Other Study ID Numbers: 20040138, HALT Prostate Cancer
Study First Received: August 9, 2004
Results First Received: July 2, 2010
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Prostate Cancer
Bone Loss with Prostate Cancer
Treatment of bone loss in patients undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer (PC).

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014