Among postmenopausal women with osteoporosis at risk of fracture, daily injection of the drug abaloparatide for 18 months significantly reduces the risk of new vertebral and non-vertebral fractures compared with placebo, according to a new study published in JAMA.
Osteoporosis is associated with substantial social, economic, and public health burdens. Based on 2010 US Census data, a study estimated the prevalence of women with osteoporosis aged 50 to 69 years at 3.4 million. It has been estimated that the lifetime risk of osteoporotic fracture for a 60-year-old woman is 44 per cent. 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 Miller, of the Colorado Center for Bone Research, Lakewood, and colleagues randomly assigned postmenopausal women with osteoporosis to receive daily injections for 18 months of placebo, abaloparatide or teriparatide. The trial was conducted at 28 sites in 10 countries.
Among 2463 women (average age, 69 years), 1901 completed the study. New vertebral fractures occurred less frequently in the active treatment groups vs placebo, and the estimated event rate for non-vertebral fracture was lower with abaloparatide vs placebo.
Bone mineral density (BMD) increases were greater with abaloparatide than placebo; while incidence of hypercalcaemia was lower with abaloparatide than with teriparatide. 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.
References: Claus Christiansen, M.D., et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. DOI: 10.1001/jama.2016.11136
Cappola, A.R., Shoback, D.M. Osteoporosis therapy in postmenopausal women with high risk of fracture. JAMA. DOI:10.1001/jama.2016.11032