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Prolia® (Denosumab) Phase 2 Extension Study Showed Continued Increase in Bone Mineral Density Over Eight Years of Treatment
Date:9/17/2011

ck) were enrolled. Of the 262 women who completed the parent study, 200 enrolled in the extension study, all of whom received Prolia (60 mg every 6 months). Results focused on patients who received Prolia treatment for up to eight years, where BMD showed gains at the lumbar spine and total hip of 16.8 percent and 6.9 percent, respectively, compared with their parent study baseline.

Osteoporosis: Impact and Prevalence

Referred to as a "silent epidemic" by the International Osteoporosis Foundation (IOF), osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization has officially declared osteoporosis a public health crisis, and the IOF is urging governments worldwide to make osteoporosis a healthcare priority.

Osteoporosis-associated fractures are a significant cause of mortality and morbidity. In 2000, the number of osteoporotic fractures in Europe was estimated at 3.79 million, of which 890,000 were hip fractures.(1) Since 2001, the incidence of hip fractures in European countries has risen significantly.(2) In the United States (U.S.), the number of fractures due to osteoporosis is expected to rise to more than three million by 2025.(3)

The direct medical cost of osteoporotic fractures in Europe is expected to rise from euro 31.7 billion in 2000 to  euro 76.7 billion in 2050.(4) In 2005, osteoporosis-related fractures were responsible for an estimated $19 billion in cost in the U.S., and this cost is expected to rise to approximately $25 billion by 2025.(5)

About Prolia

Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).

Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for
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SOURCE Amgen
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1. Treatment With Prolia® (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate
2. 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
3. XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
4. Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
5. Results Published in The Lancet Demonstrate Superiority of XGEVA™ (Denosumab) in the Prevention of Bone Complications for Men With Bone Metastases From Advanced Prostate Cancer
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