Phase III BRIDGE study of romosozumab shows significant bone mineral density (BMD) gains in osteoporotic men.-Amgen + UCB

Amgen and UCB today announced results from the Phase III 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 full findings will be presented for the first time at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington, D.C.

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. All patients received daily calcium and vitamin D. The primary endpoint was met, with romosozumab demonstrating a statistically significant increase (12.1 percent; p<0.01) in bmd at the lumbar spine as assessed by dual energy x-ray absorptiometry compared with placebo at 12 months. all secondary endpoints were also met with romosozumab showing a statistically significant increase in bmd at total hip 2.5 percent and the femoral neck 2.2 percent at 12 months both p><0.01 compared to placebo. a statistically significant increase in bmd at six months was also seen with romosozumab at all sites examined compared to placebo: lumbar spine 9.0 percent total hip 1.6 percent femoral neck 1.2 percent p><0.01 for all sites. the dual effect of romosozumab was reflected by an increase in p1np 86 percent median increase from baseline peaking at one month a marker of bone formation and a decrease in ctx 31 percent median decrease from baseline at one month a marker of bone resorption. the overall incidence of adverse events and serious adverse events were balanced between treatment groups. the most frequently reported adverse events greater than five percent in the romosozumab arm were nasopharyngitis back pain hypertension headache and constipation. injection site reactions were reported in 5.5 percent of patients in the romosozumab treatment group and 3.7 percent in the placebo group during the 12-month period.>

Comment:The BRIDGE study is part of the comprehensive Phase III program for romosozumab and complements positive results from two additional studies at the ACR/ARHP Annual Meeting focusing on romosozumab in postmenopausal women with osteoporosis - the FRAME study (abstract #1023) and the STRUCTURE study (abstract #1024).