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Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
Date:3/23/2011

THOUSAND OAKS, Calif., March 23, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced new long-term data showing that during the fourth and fifth years of Prolia® (denosumab) treatment, postmenopausal women with osteoporosis receiving Prolia continued with further, statistically significant, year-over-year increases in lumbar spine and total hip bone mineral density (BMD), a key measurement of bone strength. The overall adverse event profile was similar for the fourth and fifth years of consecutive Prolia treatment.

The data, which were presented at the annual European Congress Osteoporosis and Osteoarthritis (ECCEO11-IOF) in Valencia, Spain, showed that treatment with Prolia, the first and only approved RANK Ligand inhibitor for the treatment of postmenopausal osteoporosis, resulted in robust BMD gains after five continuous years of treatment (13.7 percent for lumbar spine BMD and 7.0 percent for total hip BMD).  

The FREEDOM Study and the 5-Year Prolia Data The pivotal FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) study established the efficacy and safety of Prolia based on three years of data from approximately 7,800 postmenopausal women. The open-label extension of FREEDOM 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 FREEDOM study continued enrollment in the extension study; 2,343 women continued to receive Prolia treatment, and 2,207 transitioned from placebo to Prolia.

Continued treatment with Prolia resulted in consistent year-over-year gains in BMD at the lumbar spine and total hip. In years 4 and 5 respectively, women taking Prolia experienced further 1.9 percent and 1.7 percent increases in lumbar spine BMD and further 0.7 percent and 0.6 percent increases in total hip BMD (all P<0.0001 comp
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SOURCE Amgen
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