(HealthDay)—Romosozumab treatment followed by alendronate is linked to reduced risk of fractures versus alendronate alone for postmenopausal women with osteoporosis, according to a study published online Sept. 11 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the American Society for Bone and Mineral Research, held from Sept. 8 to 11 in Denver.
Kenneth G. Saag, M.D., from the University of Alabama in Birmingham, and colleagues randomized 4,093 postmenopausal women with osteoporosis and a fragility fracture to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months, followed by open-label alendronate in both groups.
The researchers found that the risk of new vertebral fracture was 48 percent lower in the romosozumab-to-alendronate versus the alendronate-to-alendronate group (6.2 versus 11.9 percent; P < 0.001), over a period of 24 months. Clinical fractures occurred in 9.7 and 13.0 percent of patients in the romosozumab-to-alendronate and the alendronate-to-alendronate groups, respectively (27 percent lower risk with romosozumab; P < 0.001). The risk of nonvertebral fractures was 19 percent lower in the romosozumab-to-alendronate versus the alendronate-to-alendronate group (8.7 versus 10.6 percent; P = 0.04) and the risk of hip fracture was 38 percent lower (2.0 versus 3.2 percent; P = 0.02).
"In postmenopausal women with osteoporosis who were at high risk for fracture, romosozumab treatment for 12 months followed by alendronate resulted in a significantly lower risk of fracture than alendronate alone," the authors write.
The study was partially funded by Amgen, the manufacturer of romosozumab.
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