Amgen and UCB announced top-line results from the Phase 3 FRAME study evaluating the safety and efficacy of romosozumab for the treatment of osteoporosis in postmenopausal women.
FRAME (FRActure study in postmenopausal woMen with ostEoporosis) is a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group Phase 3 trial of romosozumab in postmenopausal women with osteoporosis. The study compared 12 months of romosozumab treatment to placebo followed by 12 months of open-label denosumab treatment for both arms. The co-primary endpoints were the reduction of the incidence of new vertebral fracture in women with postmenopausal osteoporosis through months 12 and 24.
Data from the study showed that FRAME met the co-primary endpoints. Results demonstrated that women treated with romosozumab experienced a statistically significant 73% reduction in the relative risk of a vertebral (spine) fracture through 12 months vs. placebo. Patients transitioned from romosozumab to denosumab had a statistically significant 75% reduction in the relative risk of new vertebral fracture through month 24 compared to placebo followed by denosumab. In addition, women treated with romosozumab experienced a statistically significant 36% reduction in the relative risk of a clinical fracture through 12 months compared to placebo.
Further analysis of the FRAME study data is ongoing and will be presented at a future medical conference and submitted for publication. The Companies intend to discuss these results with global regulators in anticipation for a potential filing in 2016.
Romosozumab is an investigational bone-forming monoclonal antibody designed to inhibit the protein sclerostin and to increase bone formation and decrease bone breakdown.