FRAME study of romosozumab shows significant reduction of new vertebral fractures in postmenopausal women with osteoporosis .- Amgen + UCB

Amgen and UCB announced findings from the FRAME study showing that the investigational agent romosozumab significantly reduced the incidence of new vertebral fractures in postmenopausal women with osteoporosis through 12 and 24 months, meeting the study's co-primary endpoints. The results from the Phase III study, the first to evaluate fracture risk reduction as early as one year as a primary endpoint, were published in the New England Journal of Medicine (NEJM) and presented in an oral session at the Annual Meeting of the American Society for Bone Mineral Research (ASBMR) in Atlanta . Romosozumab works by binding and inhibiting the activity of the protein sclerostin, and as a result, has a dual effect on bone, both increasing bone formation and decreasing bone breakdown.

FRAME (FRActure study in postmenopausal woMen with ostEoporosis), which enrolled 7,180 women, showed that those randomly assigned to receive a monthly subcutaneous 210 mg dose of romosozumab experienced a statistically significant 73 percent reduction in the relative risk of a new vertebral (spine) fracture through 12 months, the first co-primary endpoint, compared to those receiving placebo (fracture incidence 0.5 percent versus 1.8 percent, respectively [p<0.001]). of interest the data showed that by six months new vertebral fractures occurred in 14 romosozumab and 26 placebo patients and between six to 12 months fractures occurred in two additional romosozumab patients versus 33 additional placebo patients. for those patients who received romosozumab in year one fracture risk reduction persisted through month 24 after both groups transitioned to denosumab treatment in the second year of the study there was a statistically significant 75 percent reduction in the risk of vertebral fracture at month 24 the other co-primary endpoint in patients who received romosozumab followed by denosumab versus placebo followed by denosumab fracture incidence 0.6 percent versus 2.5 percent respectively p><0.001]). in the second year of the study new vertebral fractures occurred in five patients who transitioned from romosozumab to denosumab and 25 patients who transitioned from placebo to denosumab. when looking at clinical fractures which encompass all symptomatic fractures both non-vertebral and painful vertebral fractures patients receiving romosozumab experienced a statistically significant 36 percent reduction in the relative risk of a clinical fracture a secondary endpoint through 12 months compared to those receiving placebo fracture incidence 1.6 percent versus 2.5 percent respectively p="0.008])." a 33 percent reduction in relative risk of clinical fracture was observed through 24 months after patients transitioned from romosozumab to denosumab compared to patients transitioning from placebo to denosumab nominal p="0.002," adjusted p="0.096).">

See-Romosozumab "Treatment in Postmenopausal Women with Osteoporosis"-Felicia Cosman, M.D., Daria B. Crittenden, M.D., Jonathan D. Adachi, M.D., Neil Binkley, M.D., Edward Czerwinski, M.D., Serge Ferrari, M.D., et al.. September 18, 2016DOI: 10.1056/NEJMoa1607948.