Romosozumab shows promising reduction in vertebral fracture incidence in postmenopausal women

Postmenopausal women treated with romosozumab had a reduced incidence of new vertebral fracture through months 12 and 24, according to phase 3 results from the FRAME trial.

“These data are encouraging and in meeting to co-primary endpoints of this study, romosozumab has shown to be effective in reducing the incidence of new vertebral fractures at months 12 and 24 and for clinical fractures as early as 12 months,” Iris Loew-Friedrich, MD, PhD, chief medical officer and executive vice president of UCB, said in the release. “Deeper understanding of the results will help us sharpen the profile of romosozumab in postmenopausal women with osteoporosis.”

A monthly injection of romosozumab revealed a 73% reduction in the RR of a vertebral fracture through 12 months compared with placebo in postmenopausal women. Both groups were then treated with denosumab (Amgen) through the second year of treatment and the effect size persisted. Romosozumab followed by denosumab reduced the risk for vertebral fractures by 75% compared with placebo followed by denosumab through month 24. Clinical fracture incidence was also reduced by 36% in the group receiving romosozumab compared with placebo through month 12.

“A vertebral fracture due to osteoporosis can be a life-altering event and the risk of these kinds of fractures will be a growing burden as our society ages,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “These data show the romosozumab reduced new vertebral fracture risk as soon as 12 months.”

Serious adverse events were balanced between both groups.