To assess the effect of denosumab (dose 60 mg s.c. once in 6 months for three years) on the fracture ris in postmenopausal women (n=7868) in a double blind, pacebo controlled, randomized clinical trial. Denosumab decreased the risk of new fractures at the spine (by 68%), hip fractures (by 40%), non-vertebral fractures (by 20%).
The safety profile of denosumab was very good, comparable to placebo.