![]() ![]() New morphometric vertebral fractures occurred less frequently in the active treatment groups vs placebo. Hypercalcemia was a prespecified safety end point in abaloparatide-treated vs teriparatide participants.Īmong 2463 women (mean age, 69 years ), 1901 completed the study. Secondary end points included change in BMD at total hip, femoral neck, and lumbar spine in abaloparatide-treated vs placebo participants and time to first incident nonvertebral fracture. ![]() Sample size was set to detect a 4% difference (57% risk reduction) between treatment groups. Primary end point was percentage of participants with new vertebral fracture in the abaloparatide vs placebo groups. Postmenopausal women (>65 y) with fracture criteria and a T score ≤-2.0 and >-5.0 or without fracture criteria and a T score ≤-3.0 and >-5.0 could enroll.īlinded, daily subcutaneous injections of placebo (n = 821) abaloparatide, 80 μg (n = 824) or open-label teriparatide, 20 μg (n = 818) for 18 months. Postmenopausal women with bone mineral density (BMD) T score ≤-2.5 and >-5.0 at the lumbar spine or femoral neck and radiological evidence ≥2 mild or ≥1 moderate lumbar or thoracic vertebral fracture or history of low-trauma nonvertebral fracture within the past 5 years were eligible. The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) was a phase 3, double-blind, RCT (March 2011-October 2014) at 28 sites in 10 countries. To determine the efficacy and safety of abaloparatide, 80 μg, vs placebo for prevention of new vertebral fracture in postmenopausal women at risk of osteoporotic fracture. Abaloparatide is a selective activator of the parathyroid hormone type 1 receptor. Additional therapies are needed for prevention of osteoporotic fractures. ![]()
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