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Trial record 2 of 2 for:    20040138

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 9, 2004
First Posted Date  ICMJE August 11, 2004
Results First Submitted Date  ICMJE July 2, 2010
Results First Posted Date  ICMJE June 3, 2014
Last Update Posted Date October 17, 2018
Actual Study Start Date  ICMJE August 1, 2004
Actual Primary Completion Date May 16, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: AMG 162
    60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
  • Drug: Placebo
    60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
Study Arms  ICMJE
  • Experimental: AMG 162
    Intervention: Drug: AMG 162
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2008)
1468
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 11, 2010
Actual Primary Completion Date May 16, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Other criteria also apply
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Czech Republic,   Finland,   Hungary,   Mexico,   Netherlands,   Poland,   Switzerland,   United States
 
Administrative Information
NCT Number  ICMJE NCT00089674
Other Study ID Numbers  ICMJE 20040138
HALT Prostate Cancer
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP