Radius presents analysis from Phase 3 ACTIVE trial, data from TYMLOS studies
Radius Health presented a post-hoc analysis of Phase 3 data from different patient populations included in the ACTIVE trial, and results from preclinical studies of abaloparatide and its effect on the development and growth of osteoclasts and on bone resorption during an oral session at ENDO 2019, the Endocrine Society's Annual Meeting and Expo in New Orleans, LA.The first oral presentation titled "The Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in Postmenopausal Women with Osteoporosis and Osteoarthritis," showed that in a subpopulation of postmenopausal women from the ACTIVE study who also had osteoarthritis, abaloparatide was associated with significant reduction in new vertebral fractures as well as significant improvements in bone mineral density, versus placebo. The relationship between OA and osteoporosis is unclear but increased risk of fragility fracture has been associated with OA despite those patients having higher than average BMD. Of the 2,463 women enrolled in the Phase 3 ACTIVE trial, 888 patients with ongoing OA were identified. The most common sites of OA were at the spine and knee. At 18 months, significant increases in BMD from baseline were observed for abaloparatide versus placebo at the total hip, femoral neck, and lumbar spine; which was consistent with the overall ACTIVE population results. The second oral presentation titled "Different Effects of Abaloparatide and hPTH(1-34) on Osteoclastogenesis and Bone Resorption" used data from preclinical studies of abaloparatide. The analysis provides mechanistic explanations for the net bone gain observed in the ACTIVE trial, indicating that increased bone mass is, at least partly, the consequence of reduced osteoclast activity.