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Studies Published in the New England Journal of Medicine Highlight Potential New Option in the Treatment of Bone Loss
Date:8/11/2009

predominantly cellulitis, were reported more commonly in the denosumab group (0.4 percent vs. <0.1 percent). Mild, transient decreases in serum calcium were observed that had no apparent clinical significance.(1)

HALT Study Results: First Published Study to Demonstrate Fracture Prevention in Men with Non-Metastatic Prostate Cancer Undergoing ADT

Results from the HALT (Hormone AbLation Therapy) study in 1,468 men undergoing ADT for non-metastatic prostate cancer show that patients treated with denosumab experienced a 62 percent reduction in the risk of suffering a new vertebral fracture with denosumab compared to placebo at 36 months, with significant reduction observed as early as month-12.(2) Bone loss and increased fracture risk are serious and under-recognized consequences of ADT(6,7) and currently there are no approved therapies for these patients.

In this multi-center, randomized, double-blind, placebo-controlled study, men receiving 60 mg denosumab administered subcutaneously experienced a 6.7 percent increase in BMD at the lumbar spine compared to those receiving placebo (primary endpoint) at 24 months. Increases in BMD at the lumbar spine were observed as early as one month after starting treatment with denosumab and continued to increase throughout the study. In addition, denosumab produced significant increases in BMD at non-vertebral sites (total hip 4.8 percent, femoral neck 3.9 percent, and distal 1/3 radius 5.5 percent), compared to placebo.(2)

"Bone loss and fractures are an important but often unrecognized problem for prostate cancer survivors. Bone loss is an early adverse effect and even short-term androgen deprivation therapy negatively impacts skeletal health. Prevention of bone loss and fractures has been a key unmet medical need for men with prostate cancer," said Matthew Smith, M.D., Ph.D., study author, associate professor of me
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SOURCE Amgen Inc.
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