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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoporosis in Men

In brief

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.

Key facts

Study ID

NCT02186171

Run by

Amgen

People needed

245

Starts

2014-06-16

Expected to finish

2016-04-20

Last updated by the study team

2019-05-28

Who can join

Age: 55 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Lakewood, Colorado, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Genk, Belgium
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Liège, Belgium
• Research Site — Medellín, Antioquia, Colombia
• Research Site — Bogota, Cundinamarca, Colombia
• Research Site — Ostrava-Trebovice, Czechia
• Research Site — Pilsen, Czechia
• Research Site — Praha 11 - Chodov, Czechia
• Research Site — Aalborg, Denmark
• Research Site — Ballerup Municipality, Denmark
• Research Site — Mizunami-shi, Gifu, Japan
• Research Site — Yokohama, Kanagawa, Japan
• Research Site — Bungoono-shi, Oita Prefecture, Japan
• Research Site — Takatsuki-shi, Osaka, Japan
• Research Site — Hachioji-shi, Tokyo, Japan
• Research Site — Shinagawa-ku, Tokyo, Japan
• Research Site — Toshima-ku, Tokyo, Japan
• Research Site — Mexicali, Baja California Norte, Mexico
• Research Site — Monterrey, Nuevo León, Mexico
• Research Site — Culiacán, Sinaloa, Mexico
• Research Site — Lodz, Poland

Full record on ClinicalTrials.gov

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