Amgen Announces New Data Show Greater Bone Mineral Density Gains With Prolia vs Zoledronic Acid

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Amgen
AMGN
today announced findings from a randomized, double-blind, double-dummy, multicenter Phase 4 study showing that Prolia® (denosumab) achieved greater gains in bone mineral density (BMD) than the intravenous bisphosphonate zoledronic acid in postmenopausal women with osteoporosis following previous treatment with oral bisphosphonates. The findings were presented today at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting in Seattle. "Despite the availability of newer therapies like denosumab, bisphosphonates are commonly used first-line to treat osteoporosis," said lead investigator Paul Miller, M.D., medical director of the Colorado Center for Bone Research, Lakewood, Colo. "Our findings showed that denosumab provides significantly greater bone mineral density increases than zoledronic acid."  The 12-month study (NCT01732770) included 643 women 55 years or older who had postmenopausal osteoporosis (BMD T-score –2.5 or less at the lumbar spine, total hip, or femoral neck) and had been taking oral bisphosphonate therapy for two or more years. The women were randomized 1:1 to receive either subcutaneous denosumab (60 mg) every six months plus intravenous placebo once yearly (denosumab group, 321 participants), or
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