Waltham, MA-based Radius Health’s investigational drug abaloparatide-SC (subcutaneous) increases bone mineral density in the spine and hip in postmenopausal women with osteoporosis and may reduce their risk of vertebral and nonvertebral fractures, according to research presented April 1 at Endo 2016, the annual meeting of the Endocrine Society, in Boston.
Researchers investigated patients enrolled in the randomized, double-blind, comparative, multicenter international phase 3 ACTIVE clinical trial to evaluate the efficacy and safety of 80 µg of abaloparatide-SC for preventing fractures in otherwise healthy ambulatory postmenopausal women with osteoporosis. Overall, 2463 patients aged between 49 and 86 years were randomized to one of three treatment arms for 18 months: double-blind 80 µg of abaloparatide-SC, blind-matched placebo, or open-label 20 µg of subcutaneous teriparatide.
Abaloparatide-SC significantly increased bone mineral density in both the spine and hip and significantly reduced the risk of new vertebral and nonvertebral fractures compared with placebo regardless of baseline patient characteristics, including age, bone mineral density, and history of prior fractures.
The drug also reduced major osteoporotic fractures by 55% compared with teriparatide and increased bone density to a greater extent in the hip region compared with teriparatide.
Radius Health funded the study.