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Late-stage study shows Amgen and UCB's romosozumab significantly increases bone mineral density in men with osteoporosis

Published 11/13/2016, 07:52 PM
Late-stage study shows Amgen and UCB's romosozumab significantly increases bone mineral density in men with osteoporosis
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  • Results from a Phase 3 clinical trial, BRIDGE, assessing Amgen (NASDAQ:AMGN) and co-developer UCB's (OTCPK:UCBJF)(OTCPK:UCBJY) romosozumab (AMG 785) in men with osteoporosis showed statistically significant bone mineral density (BMD) gains compared to placebo. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
  • The study randomized 245 men 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once per month for 12 months. The primary endpoint, the increase in BMD at the lumbar spine at Month 12 versus placebo, was achieved (12.1%; p<0.01). All secondary endpoints were also met.
  • Romosozumab is a monoclonal antibody that inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. It has a dual effect of increasing bone formation and decreasing bone breakdown.
  • Worldwide, 20% of men over the age of 50 will experience an osteoporosis-related fracture.
  • The companies plan to discuss the data with global regulatory authorities.
  • Previously: Amgen's romosozumab successful in late-stage study in men with osteoporosis (March 21)

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