Authors: Felicia Cosman, Gary Hattersley, Ming-yi Hu, Gregory C. Williams, Lorraine A. Fitzpatrick, Dennis M. Black
Summary:
Abaloparatide-SC is a novel 34-amino acid peptide created to be a potent and selective activator of the parathyroid hormone 1 (PTH1) receptor signaling pathway. In the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) Phase 3 trial (NCT01343004) abaloparatide reduced new morphometric vertebral fractures by 86% compared with placebo (p < 0.001) and nonvertebral fractures by 43% (p = 0.049) in postmenopausal women with osteoporosis. Abaloparatide-SC increased bone mineral density (BMD) 3.4% at the total hip, 2.9% at the femoral neck, and 9.2% at the lumbar spine at 18 months (all p < 0.001 vs placebo). The analysis reported here was designed to evaluate whether fracture risk reductions and BMD accrual were consistent across different levels of baseline risk. Risk factor subgroups were predefined categorically for BMD T-score of the lumbar spine, total hip, and femoral neck (≤-2.5 vs >-2.5 and ≤-3.0 vs >-3.0), history of nonvertebral fracture (yes vs no), prevalent vertebral fracture (yes vs no), and age (<65 vs 65 to <75 vs ≥75 years old) at baseline. Forest plots show that there were no clinically meaningful interactions between any of the baseline risk factors and the treatment effect of abaloparatide-SC on new morphometric vertebral fractures, nonvertebral fractures, or BMD increases. Abaloparatide provides protection against fractures consistently across a wide variety of ages and baseline risks, including those with and without prior fractures, and it has potential utility for a broad group of postmenopausal women with osteoporosis.
Source:
Journal of Bone and Mineral Research; 2016