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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

rm group experienced significant mean increases in BMD for cumulative 6-year gains of 15.2 percent at the lumbar spine and 7.5 percent at the total hip. Fracture incidence remained low in the long-term group. During the first three years of the extension study, the cross-over group had significant mean gains of 9.4 percent at the lumbar spine and 4.8 percent at the total hip; yearly incidences of new vertebral and nonvertebral fractures were lower than in the pivotal Phase 3 fracture study placebo group.  

Incidences of adverse events (AEs) and serious AEs did not increase over time with Prolia treatment. Four subjects developed osteonecrosis of the jaw (ONJ) during the extension study that healed without further complications. One of these subjects continued Prolia, and one subject discontinued. Follow-up is ongoing for the other two subjects. No atypical femoral fractures were reported in either group.

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-relat
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SOURCE Amgen
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1. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
2. Prolia® (Denosumab) Phase 2 Extension Study Showed Continued Increase in Bone Mineral Density Over Eight Years of Treatment
3. Treatment With Prolia® (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate
4. 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
5. XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
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