Amgen and UCB announce positive top-line results from Phase III study of romosozumab

Results from the FRAME study showed that women receiving subcutaneous injection of romosozumab monthly experienced a 73% reduction in the relative risk of a vertebral fracture through 12 months compared to those receiving placebo.

"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," said Sean E. Harper, executive vice president of R&D at Amgen. "These data show that romosozumab reduced new vertebral fracture risk as soon as 12 months."

Results from the FRAME study showed that women receiving subcutaneous injection of romosozumab monthly experienced a statistically significant 73% reduction in the relative risk of a vertebral (spine) fracture through 12 months compared to those receiving placebo. The effect size persisted after both groups were transitioned to denosumab through the second year of treatment. Specifically, through month 24, romosozumab followed by denosumab reduced the relative risk of new vertebral fracture by a statistically significant 75% compared to placebo followed by denosumab. In addition, patients receiving romosozumab experienced a statistically significant 36% reduction in the relative risk of a clinical fracture through 12 months compared with those receiving placebo.

"These data are encouraging and in meeting the 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," said Professor Dr Iris Loew-Friedrich, chief medical officer and executive vice president, UCB. "Deeper understanding of the results will help us to sharpen the profile of romosozumab in postmenopausal women with osteoporosis."