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Abaloparatide

Abaloparatide is a parathyroid hormone-related protein (PTHrP) analog drug in clinical development for treating osteoporosis. Like the related drug teriparatide, and unlike bisphosphonates, it is an anabolic (i.e., bone growing) agent.

A subcutaneous injection formulation of the drug has completed a Phase III trial for osteoporosis. A transdermal patch is also in development.

JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136.

Results Among 2463 women (mean age, 69 years [range, 49-86]), 1901 completed the study. New morphometric vertebral fractures occurred 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% CI, −5.42 to −2.10]; relative risk, 0.14 [95% CI, 0.05-0.39]; P < .001), and 0.84% (n = 6) of the teriparatide group. The Kaplan-Meier estimated event rate for nonvertebral fracture was 2.7% for abaloparatide, 4.7% for placebo (RD, −2.01 [95% CI, −4.02 to −0.00]; hazard ratio [HR], 0.57 [95% CI, 0.32-1.00]; P = .049), and 3.3% for teriparatide. BMD increases 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).

Phase II results were encouraging.