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Denosumab for prevention of fractures in postmenopausal women with osteoporosis
New England Journal of Medicine, 08/24/09

Cummings SR et al. – Study shows that denosumab given subcutaneously twice yearly for 36 months was associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis.

• An investigation of whether denosumab can reduce the risk of fractures in osteoporotic women
• 7868 women; age: 60-90 yrs who had a bone mineral density T score of < -2.5 but not < -4.0 at the lumbar spine or total hip
• Subjects were randomly assigned to receive either 60 mg of denosumab or placebo sc every 6 mo for 36 mo
• Primary end point: new vertebral fracture
• Secondary end points: nonvertebral and hip fractures

• Denosumab reduced the risk of new radiographic vertebral fracture, with a relative decrease of 68%
• Denosumab reduced the risk of hip fracture, with a relative decrease of 40%
• Denosumab also reduced the risk of nonvertebral fracture, with a relative decrease of 20%
• No increase in the risk of cancer, infection, cardiovascular disease, delayed fracture healing, or hypocalcemia
• No cases of osteonecrosis of the jaw and no adverse reactions to the injection of denosumab

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