Radius Health initiates Phase 3 study of abaloparatide in osteoporosis
Radius Health announced that the company has initiated the Phase 3 Atom study of abaloparatide injection for the treatment of osteoporosis in men. "Approximately 20 percent of men over the age of 50 years will sustain an osteoporotic-related fracture in their lifetime attributed to multiple risk factors. If successful, this study will serve as the basis of a supplemental New Drug Application (sNDA) seeking to expand the use of abaloparatide to treat men with osteoporosis at high risk for fracture," said Gary Hattersley, PhD, Chief Scientific Officer of Radius Health. "The study will also include specialized high-resolution imaging to examine the effect of abaloparatide on bone structure, such as the hip, in a subset of the study participants." The primary endpoint of the male osteoporosis study is change in lumbar spine bone mineral density at 12 months compared with placebo. The randomized, double-blind, placebo-controlled trial will enroll approximately 225 men with osteoporosis. Abaloparatide, marketed as Tymlos, was approved in April 2017 by the FDA for the treatment of postmenopausal women with osteoporosis at high risk for fracture.