Amgen Inc. and UCB SA have announced results from the Phase 3 BRIDGE study showing that in men with osteoporosis, the investigational agent romosozumab resulted in significant bone mineral density (BMD) gains at the lumbar spine, total hip and femoral neck compared to placebo at six and 12 months.
The BRIDGE study (placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis) involved 245 men with osteoporosis (163 romosozumab, 82 placebo) randomized 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once monthly for 12 months.
“Romosozumab has the ability to improve bone mass, structure and strength by both increasing bone formation and decreasing bone resorption, ” said E. Michael Lewiecki, M.D., principal investigator for the BRIDGE study and clinical assistant professor of medicine, University of New Mexico School of Medicine, in the November 12, 2016 news release.
Dr. Lewiecki told OTW, “The results from the BRIDGE study are promising as they show the clinical effects of romosozumab in men with osteoporosis—a population that is often under-recognized and under-treated for a condition that can have devastating consequences. One in five men over the age of 50 worldwide will have an osteoporosis-related fracture—an incidence that is greater than the development of prostate cancer. Since men with fragility fractures are at very high risk for another fracture, it is important that they are evaluated and treated to reduce fracture risk.”
“The findings of this study confirm the dual action of romosozumab and ability to improve bone mass, structure and strength by both increasing bone formation and decreasing bone resorption. The dual effect of romosozumab was reflected by an increase in P1NP (86% median increase from baseline peaking at one month), a marker of bone formation, and a decrease in CTX (31% median decrease from baseline at one month), a marker of bone resorption, leading to a robust increase in bone mineral density (12.2% increase at the lumbar spine after 12 months) which was already significant after 6 months.”
“The BRIDGE results are encouraging and reinforce the potential of romosozumab as a promising treatment for osteoporosis. Amgen and UCB who are co-developing romosozumab will be discussing these Phase 3 BRIDGE results with global regulators.”
