A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Percent Change From Baseline to Week 13 in uNTx/Cr
Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Percent change from baseline to week 13 calculated using ((week 13 value - baseline value) / baseline value ) x 100.
Baseline and week 13
Australia: Human Research Ethics Committee