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Providence health system shows investigational osteoporosis therapy increases bone mineral density

Providence Health System researchers announced today that an investigational therapy for bone loss, denosumab, demonstrated significant increases in bone mineral density (BMD) in postmenopausal women with osteoporosis. Many older adults experience bone loss that leads to low BMD and fractures. Bone mineral density is often used to gauge a person's risk of fracture. These research findings, which were published in the Feb. 23, 2006 issue of The New England Journal of Medicine, are significant especially in light of the recent Surgeon General's report on bone health. The report highlights the need for new, improved approaches to prevention and treatment of osteoporosis and other bone loss conditions.

The article summarizes the results of the phase 2, multi-center trial evaluating the effect of denosumab in postmenopausal women with low BMD. Denosumab is a RANK Ligand inhibitor under development by Amgen, Inc. of Thousand Oaks, Calif. The investigational therapy is designed to target RANK Ligand, a protein that is the primary mediator of osteoclast formation, function and survival. Osteoclasts are the cells responsible for bone removal.

"We are very encouraged by the study's results," said Michael McClung, MD, FACP, principal investigator of the denosumab study and director of Oregon Osteoporosis Center at Providence Portland Medical Center in Portland, Ore. "These data document that targeting the RANK Ligand pathway may provide a new treatment option for bone loss diseases including osteoporosis."

The phase 2 data indicated that denosumab provides rapid and sustained responses of bone metabolism in patients with low BMD. Denosumab, when administered twice yearly, increased total hip, spine, distal 1/3 radius and total body BMD similar to current therapy in the one-year trial. Researchers reported that subcutaneous injections of denosumab significantly increased BMD at the lumbar spine from 3.0 to 6.7 percent after 12 months as
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Contact: Paula Gunness
paula.gunness@providence.org
503-215-6433
Porter Novelli
22-Feb-2006


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