Amgen and UCB have reported positive results from its Phase III BRIDGE study of romosozumab for treating men with osteoporosis.
The placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis (BRIDGE) study was held as a multicentre, international, randomised, double-blind, placebo-controlled study examining 245 men with osteoporosis.
The patients were randomised to receive a subcutenous administration of romosozumab or placebo for a year and received calcium and vitamin D on a daily basis.
The BRIDGE study is a part of a comprehensive Phase III programme for romosozumab.
Results from the study showed that in males with osteoporosis, romosozumab increased bone mineral density (BMD) at the lumbar spine, total hip and femoral neck in comparison to placebo at six and 12 months.
The study also met its secondary endpoint of romosozumab achieving BMD gains at total hip and the femoral neck at 12 months.
BRIDGE study principal investigator and University of New Mexico School of Medicine clinical assistant professor of medicine Michael Lewiecki said: "Romosozumab has the ability to improve bone mass, structure and strength by both increasing bone formation and decreasing bone resorption.
"These Phase III findings are particularly promising as they show the clinical effects of romosozumab in men with osteoporosis a population that is often under-recognised and under-treated for a disease that can have devastating consequences."
Romosozumab has been developed as a humanised monoclonal antibody that fuses and inhibits sclerostin, a protein secreted by bone cells that prevents bone formation.
