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

• Status: Completed
• Trial end date: 2016-04-20
• Target enrollment: 0
• Participant gender: Male

Summary

The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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 fracture.

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