A Double-blind Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

This is a multicenter, randomized, double-blind, placebo-controlled study in approximately
225 men with osteoporosis. The study is designed to evaluate if treatment with romosozumab
once a month for 12 months compared with placebo is effective in increasing BMD at the lumbar
spine. Additionally, the study will assess the effect of treatment with romosozumab for 12
months compared with placebo on BMD at the femoral neck and total hip.

Inclusion Criteria:

- Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age

- Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the
spine or hip and a history of fragility nonvertebral fracture or vertebral facture.

Exclusion Criteria:

- A BMD T score ≤ -3.50 at the hip,

- History of hip fracture

- Severe metabolic bone diseases

- Significant laboratory abnormalities

- Recent treatment with agents affecting bone metabolism