Abaloparatide-SC: Extension study data
Top-line data from the 24-month, open-label, international ACTIVExtend extension trial of the double-blind, placebo-controlled, 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 in ACTIVE followed by alendronate for 6 months reduced the incidence of new vertebral fractures by 87% (p<0.0001), non-vertebral fractures by 52% (p=0.0168), clinical fractures by 48% (p=0.0139) and major osteoporotic fractures by 58% (p=0.0122) from baseline of ACTIVE over the 25-month period. Additionally, there have been no new vertebral fractures during the first 6 months of ACTIVExtend in patients previously treated with abaloparatide-SC vs. 6 fractures in patients who received placebo for 18 months in ACTIVE and then were switched to alendronate. Additionally, patients who received abaloparatide-SC followed by alendronate had a 12.8% increase in bone mineral density (BMD) at the lumbar spine, a 5.5% increase in BMD at total hip and a 4.5% increase in BMD at the femoral neck over 25 months. Furthermore, an exploratory analysis of the ACTIVE trial showed that abaloparatide-SC reduced major osteoporotic fractures by 67% vs. placebo (p=0.0014) and by 53% vs. the active comparator once-daily 20 ug Forteo teriparatide (p=0.0437). ...