Amgen, UCB’s Romosozumab Minimizes Vertebral Fracture Risk in Phase III
Amgen and UCB announced results from a Phase III trial that showed 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 study, which enrolled 7,180 women, showed that those receiving a monthly subcutaneous 210 mg dose of romosozumab experienced a 73 percent reduction in the relative risk of new vertebral fractures through 12 months, compared to those receiving placebo.
By six months, new vertebral fractures occurred in 14 romosozumab and 26 placebo patients, and between six and 12 months, fractures occurred in two additional romosozumab patients versus 33 additional placebo patients. The results were published in the New England Journal of Medicine and presented at the annual meeting of the American Society for Bone and Mineral Research.
Both groups transitioned to Prolia (denosumab) treatment in the second year of the study, and in patients who received romosozumab in year one, fracture risk reduction persisted through month 24. Romosozumab treatment also resulted in a 25 percent reduction in the risk of non-vertebral fractures in the first year, compared to placebo, but the reduction was not considered statistically significant.