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Romosozumab Phase 2 Data Published In New England Journal Of Medicine Show Significant Increases In Bone Mineral Density At Both Spine And Hip
Date:1/1/2014

THOUSAND OAKS, Calif. and BRUSSELS, Jan. 1, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels:UCB) today announced results from a Phase 2 trial evaluating romosozumab (AMG 785/CDP7851) in postmenopausal women with low bone mineral density (BMD). Published in the New England Journal of Medicine (NEJM), the trial demonstrated that, compared with placebo, romosozumab treatment for 12 months significantly increased BMD at the lumbar spine, total hip and femoral neck. Significant increases were also observed in the first BMD assessment at three months. Moreover, in exploratory analyses, increases observed at the lumbar spine and hip were significantly greater than those observed with current treatments FOSAMAX® (alendronate sodium) and FORTEO/FORSTEO® (teriparatide).1   

"The results of the study demonstrate significantly increased BMD and stimulation of bone formation with romosozumab treatment in women with postmenopausal osteoporosis," said Michael McClung, M.D., director of the Oregon Osteoporosis Center and lead study investigator. "Additionally, romosozumab treatment resulted in greater increases in bone mineral density than those seen with both placebo and the active comparators. These data provide important insight into this medicine being developed for women with postmenopausal osteoporosis at high risk for fractures." 

Romosozumab is an investigational medicine in Phase 3 clinical development for the treatment of osteoporosis in postmenopausal women and is not currently approved by any regulatory authority.

In this Phase 2 trial, each of the five romosozumab dose regimens significantly increased BMD compared with pooled placebo groups at the lumbar
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SOURCE Amgen
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