August 16, 2016

Abaloparatide Reduces Risk of Fracture Among Women With Osteoporosis

PARSIPPANY, NJ -- August 16, 2016 -- Among postmenopausal women with osteoporosis at risk of fracture, daily injection of the drug abaloparatide for 18 months significantly reduced the risk of new vertebral and nonvertebral fractures compared with placebo, according to a study appearing in the August 16 issue of JAMA.

Osteoporosis is associated with substantial social, economic, and public health burdens. Based on 2010 US Census data, a study estimated the prevalence of osteoporosis among women 50 to 69 years of age at 3.4 million. It has been estimated that the lifetime risk of osteoporotic fracture for a 60-year-old woman is 44%. Additional therapies are needed for prevention of osteoporotic fractures. As a result of its mechanism of action, it has been hypothesised that the drug abaloparatide, a synthetic peptide, would have a more pronounced anabolic action on bone compared with the osteoporosis drug teriparatide.

Paul D. Miller, MD, Colorado Center for Bone Research, Lakewood, Colorado, and colleagues randomly assigned postmenopausal women with osteoporosis to receive daily injections for 18 months of placebo (n = 821); abaloparatide (n = 824); or teriparatide (n = 818). The trial was conducted at 28 sites in 10 countries.

Among 2,463 women (average age, 69 years), 1,901 completed the study. New vertebral fractures occurred less frequently in the active treatment groups versus placebo: in 0.58% (n = 4) of participants in the abaloparatide group; in 0.845 (n = 6) of participants in the teriparatide group; and in 4.225 (n = 30) of those in the placebo group. The estimated event rate for nonvertebral fracture was lower with abaloparatide versus placebo: 2.7% in the abaloparatide group; 3.3% in the teriparatide group; and 4.7% in the placebo group.

Bone mineral density (BMD) increases were greater with abaloparatide than placebo. Incidence of hypercalcaemia was lower with abaloparatide (3.4%) versus teriparatide (6.4%). Overall, there were no differences in serious adverse events between the treatment groups.

“Further research is needed to understand the clinical importance of risk difference, the risks and benefits of abaloparatide treatment, and the efficacy of abaloparatide versus other osteoporosis treatments,” the authors write.

SOURCE: JAMA
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