The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
252
60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 12 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 6 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 12 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 6
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 6 months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 12 months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 6 months
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