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    Can injectable abaloparatide reduce fractures?

    According to results of a recent study published in JAMA, use of subcutaneous abaloparatide may reduce fractures in postmenopausal women with osteoporosis.

    The study was a phase 3, double-blind, randomized control trial that ran from March 2011 to October 2014 at 28 sites in 10 countries. Postmenopausal women with bone mineral density (BMD) T scores ≤ −2.5 and > −5.0 at the lumbar spine or femoral neck and radiological evidence of ≥2 mild or ≥1 moderate lumbar or thoracic vertebral fracture or a history of any low-trauma nonvertebral fracture within the past 5 years were eligible to be included. Participants were assigned to daily subcutaneous injections of blinded placebo (n = 821); abaloparatide, 80 μg (n = 824); or open-label teriparatide, 20 μg (n = 818) over the course of 18 months.

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    Overall 2463 women (average age, 69 years [range, 49-86]) enrolled and 1901 completed the study. New morphometric vertebral fractures happened in 0.58% (n = 4) of the abaloparatide group; 4.22% (n = 30) of the placebo group (risk difference [RD] vs placebo, −3.64 [95% confidence interval {CI}, −5.42 to −2.10]; relative risk, 0.14 [95% CI, 0.05-0.39]; P < .001); and 0.84% (n = 6) in the teriparatide group. The Kaplan-Meier estimated event rate was 3.3% for teriparatide; 2.7% for abaloparatide; and 4.7% for placebo (RD, −2.01 [95% CI, −4.02 to −0.00]; hazard ratio, 0.57 [95% CI, 0.32-1.00]; P = .049). Increases in BMD were greater with abaloparatide than with placebo (all P < .001). Incidence of hypercalcemia was lower with abaloparatide (3.4%) than with teriparatide (6.4%) with an RD of -2.96 (95% CI, −5.12 to −0.87; P = .006).

    The researchers concluded that subcutaneous abaloparatide, when compared to placebo, reduced  risk of new fractures over 18 months. They urged further research to understand the clinical importance of RC, the risk versus benefit profile of abaloparatide treatment, and to compare the efficacy of abaloparatide to other treatments.

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    Miranda Hester
    Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

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