BOSTON — The investigational drug abaloparatide, a 34-amino acid osteoanabolic peptide, increased bone mineral density and reduced fractures in postmenopausal women regardless of baseline risk, according to data presented here.
Felicia Cosman, MD, an endocrinologist at Helen Hayes Hospital Regional Bone Center in West Haverstraw, New York, and professor of medicine at Columbia University, and colleagues performed a prespecified subgroup analysis of data from 2,463 postmenopausal women with osteoporosis (aged 49-86 years; mean age, 69 years) enrolled in the phase 3 ACTIVE trial. Participants were randomly assigned 80 g subcutaneous abaloparatide (n = 824) or placebo (n = 821), or open-label 20 g subcutaneous teriparatide (n = 818).
At 18 months, participants assigned abaloparatide had a 9.2% increase in BMD from baseline at the lumbar spine, 3.4 % at the total hip 3.4% and 2.9% at the femoral neck compared with placebo (P < .0001 for all). Morphometric vertebral fractures were reduced by 86% (P < .0001), nonvertebral fractures by 43% (P = .0489) and major osteoporotic fractures by 70% (P = .0004) in the abaloparatide group compared to placebo. Compared with teriparatide, major osteoporotic fractures were reduced by 55% in the aloparatide group (P = .0309).
For the subgroup analysis, participants assigned abaloparatide were categorized according to 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 fracture history (yes or no); prevalent vertebral fracture (yes or no) and age at baseline (< 65 vs. 65 to < 75 vs. 75 years).
Reductions in new morphometric vertebral and nonvertebral fractures were similar across subgroups, as were increases in BMD, and researchers observed no meaningful interactions between baseline risk factor subgroups and treatment effects.
“Our findings suggest that abaloparatide-SC, if approved, has the potential to provide consistent protection against fractures and to increase BMD in a broad group of postmenopausal women with osteoporosis, regardless of baseline age, BMD or prior fracture history,” Cosman said.
Drug developer Radius Health submitted a New Drug Application to the FDA for abaloparatide on March 30. The company submitted a Marketing Authorization Application in Europe on Nov. 17 last year. – by Jill Rollet
Cosman F, et al. OR01-2. Presented at: The Endocrine Society Annual Meeting; April 1-4, 2016; Boston.
Disclosure: Cosman reports consulting for Amgen, Eli Lilly, Merck and Radius Health, and receiving lecture fees and grant support from Amgen and Eli Lilly. Please see the full study for a list of all other authors’ relevant financial disclosures.