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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:
ClinicalTrials.gov Identifier:
NCT00089674
First Posted: August 11, 2004
Last Update Posted: March 21, 2016
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.
Information provided by (Responsible Party):
Amgen
August 9, 2004
August 11, 2004
July 2, 2010
June 3, 2014
March 21, 2016
August 2004
June 2008   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00089674 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
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
This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • Experimental: AMG 162
    Intervention: Drug: AMG 162
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1468
July 2010
June 2008   (Final data collection date for primary outcome measure)
Other criteria also apply
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   Czech Republic,   Finland,   Hungary,   Mexico,   Netherlands,   Poland,   Switzerland,   United States
 
NCT00089674
20040138
HALT Prostate Cancer
Not Provided
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
February 2016

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