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Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Six Years With Similar Safety Profile Observed in Original Fracture Trial
Date:11/5/2011

THOUSAND OAKS, Calif., Nov. 5, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive data from the first three years of the open-label extension study of the pivotal Phase 3 fracture trial showing that six years of Prolia® (denosumab) treatment in postmenopausal women with osteoporosis was associated with continued increase in bone mineral density (BMD) and consistent reduction in markers of bone turnover. These results will be presented on Nov. 8, 2011, at the 2011 American College of Rheumatology Annual Scientific Meeting in Chicago.

Results of the open-label extension study showed that postmenopausal women with osteoporosis who received up to six years of continued Prolia treatment experienced cumulative gains of 15.2 percent at the lumbar spine and 7.5 percent at the total hip compared with baseline. The overall adverse event profile is consistent with events previously reported.

"These data are consistent with the pivotal Phase 3 fracture study, which first established the efficacy and safety of Prolia in women with postmenopausal osteoporosis at high risk for fractures," said study author Jacques Brown, M.D., CHUQ-CHUL Research Centre, Laval University. "This study provides further evidence of Prolia's long-term clinical potential for women with this chronic disease."

The FREEDOM Study and the 6-Year Prolia Data

The pivotal Phase 3 fracture trial was based on three years of data from approximately 7,800 postmenopausal women. The open-label study extension is evaluating the long-term (up to 10 years) efficacy and safety of Prolia in 4,550 postmenopausal women. Seventy percent of eligible women from the pivotal Phase 3 fracture study enrolled in the study extension; 2,343 women continued to receive Prolia treatment (long-term group), and 2,207 transitioned from placebo to Prolia (cross-over group).

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SOURCE Amgen
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