This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,468
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 36 months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 36 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 36 months
Number of Participants With Any Fracture Through Month 36
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Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.
Time frame: 36 months
Number of Participants With a New Vertebral Fracture Through Month 36
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 frame: 36 months
Time to First Clinical Fracture Through Month 36
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.
Time frame: 36 months
Number of Participants With Any Fracture Through Month 24
Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.
Time frame: 24 months