Researchers from pharmaceutical companies Amgen and UCB have completed the phase-three placebo-controlled fracture study in postmenopausal women with osteoporosis (FRAME), during which the drug romosozumab was found to reduce new vertebral fractures in postmenopausal women living with osteoporosis.
The study analyzed test subjects through months 12 and 24. A secondary endpoint, reduction in the occurrence of clinical fractures, was also met.
"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 Harper, executive vice president of research and development at Amgen, said. "These data show that romosozumab reduced new vertebral fracture risk as soon as 12 months."
Subjects in the FRAME study received romosozumab monthly as a subcutaneous injection. The subjects showed a 73 percent reduction in the risk of a spine fracture through 12 months, compared to the subjects treated with a 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," Iris Loew-Friedrich, chief medical officer and executive vice president of UCB, said. "Deeper understanding of the results will help us to sharpen the profile of romosozumab in postmenopausal women with osteoporosis."
Romosozumab is an investigational bone-forming monoclonal antibody. It has not been approved by any drug regulation authority for treating osteoporosis. It works by inhibiting the protein sclerostin, which increases bone formation and decreases bone breakdown.
Romosozumab studies are continuing.
