May 11, 2017
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Abaloparatide decreases fracture risk in postmenopausal women

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Postmenopausal women treated with abaloparatide have a significantly reduced risk for morphometric vertebral fracture, clinical vertebral fracture and any clinical fracture compared with women treated with placebo, according to findings published in the Journal of Bone and Mineral Research.

Eugene V. McCloskey, MD, FRCPI, professor in the Metabolic Bone Centre, Northern General Hospital in the United Kingdom, and colleagues evaluated data from the ACTIVE study on postmenopausal women (mean age, 69 years) randomly assigned to daily placebo (n = 821) or subcutaneous abaloparatide (n = 824; Tymlos, Radius Health) for 18 months to determine the efficacy of abaloparatide as a function of baseline fracture risk. Fracture risk assessment (FRAX) models were used to calculate the 10-year probability of major osteoporotic fractures with or without femoral neck bone mineral density.

At baseline, the mean probability of major osteoporotic fractures was 13.1% in the abaloparatide group and 13.2% in the placebo group; mean probability of hip fracture was 4.7% in the abaloparatide group and 4.9% in the placebo group. The 10-year probability of hip or major osteoporotic fracture did not significantly differ between the two groups.

Compared with placebo, abaloparatide decreased the risk for morphometric vertebral fracture by 86% (P < .001), clinical vertebral fracture by 88% (P = .041) and any clinical fracture by 43% (P = .019).

“Despite a relatively low fracture incidence, the present analysis of the phase 3 ACTIVE study of abaloparatide-[subcutaneous] in postmenopausal women with low BMD and/or prior fracture shows efficacy of abaloparatide-[subcutaneous] for all fracture outcomes compared to placebo, with apparently similar efficacy across a wide range of baseline fracture risk,” the researchers wrote. – by Amber Cox

Disclosure: McCloskey reports various financial ties with ActiveSignal, Alliance for Better Bone Health, Amgen, Bayer, Boehringer Ingelheim, Consilient Healthcare, Eli Lilly, GE Lunar, GlaxoSmithKline, Hologic, Internis, Medtronic, Merck, Novartis, Pfizer, Roche, Servier, Synexus and Tethys.