Denosumab increases bone mineral density (BMD) and reduces the risk of vertebral fractures in women with postmenopausal osteoporosis, according to the results of a study published in the New England Journal of Medicine.[i]
Denosumab is an investigational drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Denosumab has shown promising results in the management of bone metastases, bone loss due to cancer treatment, and postmenopausal osteoporosis.
The FREEDOM Study involved more than 7,800 women, half of whom received denosumab twice a year for three years and the other half of whom received placebo. The results indicated that women who received denosumab were 68% less likely to suffer a vertebral fracture and 40% less likely to suffer a hip fracture than those who received placebo. Women who received denosumab experienced an 8.8% increase in BMD at the lumbar spine and 6.4% at the total hip.
Rates of serious adverse events were similar for both groups: 25.8% for denosumab and 25.1% for placebo. Serious skin infections, though rare, were more common in the denosumab group than the placebo group.
[i] Cummings SR, San Martin J, McClung MR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. New England Journal of Medicine. Early online publication August 11, 2009.
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