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.

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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.

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