Conditions: Breast Cancer Low Bone Mineral Density Osteopenia
Keywords: Breast Cancer Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC osteopenia Low bone density
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 252
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Placebo intervention 2: AMG 162 / Denosumab
Intervention descriptions: intervention 1: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months intervention 2: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

Protocol document: