Amgen and UCB announce positive Phase 3 BRIDGE results

Amgen and UCB recently announced positive high quality results from the pivotal Phase 3 placebo-controlled study evaluatIng the efficiency and safety of romosozumab in treating men with osteoporosis (BRIDGE) trial.

The data released by the two companies demonstrated that the BRIDGE study achieved its primary goal at 12 months, which was a substantial increase in bone mineral density (BMD) at the lumbar spine in men who have osteoporosis that have been treated with romosozumab as opposed to a placebo. The secondary goals of the trial were met as well, with patients given romosozumab experiencing the increase of BMD at the femoral neck and total hip at the one-year mark. These patients also experienced the same results at the lumbar spine, femoral neck and total hip at six months.

The BRIDGE study consisted of 245 men, all of whom were randomized 2:1, receiving either 210 mg of romosozumab subcutaneous (SC) every month (QM) or matched placebo SC QM over a treatment period of one year.

The patients who experienced negative effects or serious adverse events (SAEs) saw a balance between arms. The most common negative side effects were nasopharyngitis, back pain, hypertension, headache and constipation.