Treating post-menopausal osteoporosis patients with romosozumab could improve their long-term bone density and decrease the risk of spine and hip fractures, according to a randomized, multi-center, double-blind, placebo-controlled study.
Currently, there’s a gap in how best to treat post-menopausal women who suffer low bone density thanks to osteoporosis. Using romosozumab could help them ward off both vertebral and all other clinical fractures into older age. Romosozumab is an investigational, bone-forming, monoclonal antibody that binds sclerostin and increases bone formation and decreases bone resportion.
In a Sept. 18 presentation at the American Society of Bone Mineral Research annual conference in Atlanta, lead study author Helen Hayes Hospital rheumatologist Felicia Cosman, M.D., revealed FRAME study investigators wanted to identify a medication that could reverse bone loss and offer preventive care for the future.
The results of this study present "a unique opportunity for patients with osteoporosis who are at high risk for fractures and might be at imminent risk for future fractures. If they have a medication that rapidly increases bone strength and reduces fracture risk, it puts them in a better position for the next year and beyond,” she said.
Participants were post-menopausal women between ages 55 and 90 with osteoporosis. They had bone mineral density T-scores of < -2.5 at total hip or femoral neck. Co-primary endpoints were subject incidence of new vertebral fractures through M12 and M24. Secondary endpoint included clinical (nonvertebral plus symptomatic vertebral) and nonvertebral fracture, and bone mass density.
Of the 7,180 women, 89 percent completed the entire study. They were divided into a placebo group and one that received monthly 210 mg injections of romosozumab. Both groups received 60 mg of denosumab monthly for a year.
According to results, the romosozumab group experienced a 13-percent and 6.8-percent increase in bone density in the spine and hips, respectively, after one year. At the second year, the increase was 17.9 percent for spine and 8.8 percent for hips. Overall, romosozumab decreased new vertebral fracture risk by 73 percent and new clinical fractures by 36 percent.
The study received funding from Amgen Inc., and UCB Pharma.
American Society of Bone Mineral Research 2016, Abstract 1125: “Low Protein Intake Among Older Men is Associated with an Increase of Risk of Fracture,” E.V. McCloskey, M.D. Sept. 19, 2016.