Thursday, August 13, 2009

Denosumab Linked to Lower Fracture Risk in Two Groups

Non-metastatic prostate cancer and osteoporosis patients have fewer vertebral, other fracture


13 aug 2009-- Denosumab is linked to a reduction in fractures in women with osteoporosis and in men undergoing androgen-deprivation therapy for non-metastatic prostate cancer, according to two studies published online Aug. 11 in the New England Journal of Medicine.

In one study, Steven R. Cummings, M.D., of the University of California in San Francisco, and colleagues assigned 60- to 90-year-old women, who had a bone mineral density T score less than −2.5 but not less than −4 to receive 60 mg of denosumab or placebo subcutaneously every six months for 36 months. They found that denosumab, when compared with placebo, reduced the risk of radiographic vertebral fracture (cumulative incidence, 2.3 versus 7.2 percent), hip fracture (0.7 versus 1.2 percent) and non-vertebral fracture (6.5 versus 8 percent).

In the other study, Matthew R. Smith, M.D., of Massachusetts General Hospital in Boston, and colleagues randomly assigned 734 non-metastatic prostate cancer patients on androgen-deprivation therapy to receive 60 mg of denosumab subcutaneously every six months and another 734 to receive placebo. Those in the denosumab group had a decreased incidence of new vertebral fractures at 36 months (1.5 versus 3.9 percent with placebo). At 24 months, lumbar spine bone mineral density had increased by 5.6 percent in the denosumab group but decreased by 1 percent in the placebo group.

"A significant increase in bone mineral density was seen with denosumab at all measured skeletal sites, including the lumbar spine, hip, and radius. Denosumab was associated with significant decreases, as compared with placebo, in the cumulative incidence of new vertebral fractures at 12, 24, and 36 months," the authors of the second study write.

Both studies were supported by Amgen; several authors reported financial relationships with Amgen and other pharmaceutical companies.

Abstract - Cummings
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Abstract - Smith
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