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

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ClinicalTrials.gov Identifier: NCT00089674
Recruitment Status : Completed
First Posted : August 11, 2004
Results First Posted : June 3, 2014
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: AMG 162 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : August 1, 2004
Actual Primary Completion Date : May 16, 2008
Actual Study Completion Date : May 11, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Denosumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
Other criteria also apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089674


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

Publications:
Lippuner k, Wolff JM, Hadji P, Braun A, Ke C, Steinle T, Eisen C. Risk reduction for vertebral fractures in patients with normal to osteopenic bone mineral density receiving denosumab: A subgroup analysis of the HALT Prostate Cancer Trial. Osteologie 2014;23(2):117-122. [published in German only]

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00089674    
Other Study ID Numbers: 20040138
HALT Prostate Cancer
First Posted: August 11, 2004    Key Record Dates
Results First Posted: June 3, 2014
Last Update Posted: October 17, 2018
Last Verified: September 2018
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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Prostatic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs