Amgen Europe BV

This Phase 4, single-arm, open-label study 20210123 was designed to evaluate the efficacy and safety of Prolix in male subjects at high fracture risk (defined as lumbar spine or total hip BMD T-score ≤ -2.5 or ≤ -1.5 and a history of fragility fracture). Primary Objective: To evaluate the effect of Prolix on lumbar spine BMD at month 12 Secondary Objectives: To evaluate the effect of Prolix on bone turnover markers To evaluate the efficacy of Prolix on total hip, femoral neck and lumbar spine BMD To evaluate the safety of Prolix

Primary Objective: In the post-marketing setting, estimate the incidence of adverse events, serious adverse events, and adverse drug reactions (ADRs) in PMO patients treated with Prolix based on the Chinese Prescribing Information (PI) Secondary Objectives: 1) Describe the effectiveness of Prolix by assessing the percentage change from baseline in lumbar spine and/or total hip and/or femoral neck bone mineral density (BMD) (if the corresponding BMD can be obtained according to local standard of care) 2) Describe the incidence of clinical fractures during Prolix treatment 3) Describe the characteristics of patients treated with Prolix in the post-marketing setting