Promising Results for Romosozumab in Men with Osteoporosis
BRIDGE (placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn) is a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 trial in 245 men with osteoporosis, defined as low bone mineral density (BMD) at the spine, total hip or femoral neck. The trial evaluated the efficacy of romosozumab 210mg SC monthly in increasing BMD at the lumbar spine, the study's primary endpoint. Secondary endpoints include the effect of romosozumab on BMD at the femoral neck and total hip at 12 months, as well as the effect on BMD at the lumbar spine, femoral neck, and total hip at 6 months.
Study data showed that treatment with romosozumab demonstrated a statistically significant increase in BMD at the lumbar spine (as assessed by dual energy x-ray absorptiometry) compared with placebo at 12 months. Patients treated with romosozumab also achieved a statistically significant increase in BMD at the femoral neck and total hip at 12 months, and at the lumbar spine, femoral neck, and total hip at 6 months vs. placebo. Further study analysis of the BRIDGE trial is ongoing and will be presented at a future medical conference and submitted for publication.
Romosozumab, an investigational bone-forming monoclonal antibody, is designed to inhibit the protein sclerostin. It has a dual effect on bone, increasing bone formation while decreasing bone breakdown.