BioCentury
ARTICLE | Clinical News

Abaloparatide-SC: Additional Phase III data

October 19, 2015 7:00 AM UTC

Additional data from the double-blind, international Phase III ACTIVE (Study BA058-05-003) trial in 2,463 postmenopausal women with severe osteoporosis showed that once-daily 80 ug abaloparatide-SC for 18 months reduced major osteoporotic fractures by 70% vs. placebo (p=0.0004) and by 55% vs. the active comparator once-daily 20 ug Forteo teriparatide (p=0.031). Additionally, 19.1% of patients receiving abaloparatide-SC had BMD increases of >3% at the combined anatomical sites of total hip, femoral neck and lumbar spine at 6 months vs. 0.9% of patients receiving placebo and 6.5% of patients receiving Forteo (p<0.0001 for both). At 12 months, 33.2% of patients receiving abaloparatide-SC had BMD increases of >3% in the combined anatomical sites of total hip, femoral neck and lumbar spine vs. 1.5% of patients receiving placebo and 19.8% of patients receiving Forteo (p<0.0001 for both). At 18 months, 44.5% of patients receiving abaloparatide-SC had BMD increases of >3% in the combined anatomical sites of total hip, femoral neck and lumbar spine vs. 1.9% of patients receiving placebo and 32% of patients receiving Forteo (p<0.0001 for both). Data were presented at the American Society for Bone and Mineral Research meeting in Seattle. ...