Lewiecki EM, et al. – This phase 3, randomized, double-blind, placebo-controlled BRIDGE study evaluated the efficacy and safety of romosozumab in men aged 55 to 90 years with osteoporosis for 12 months. Compared with those in the placebo group, 12-month romosozumab treatment increased spine and hip bone mineral density (BMD), and was well tolerated in men with osteoporosis. Results suggested that romosozumab may be a new and promising bone-forming treatment for men with osteoporosis.

Methods

• This investigation was conducted at 31 centers in Europe, Latin America, Japan, and North America.
• Study participants were men aged 55 to 90 years with a baseline BMD T-score at the lumbar spine (LS), total hip (TH), or femoral neck of ≤-2.5 or ≤-1.5 with a history of a fragility nonvertebral or vertebral fracture.
• Participants were randomized 2:1 to receive romosozumab 210 mg subcutaneously monthly or placebo for 12 months.
• Percentage change from baseline in LS BMD at month 12 was the primary efficacy endpoint.

Results

• At month 12, the mean percentage change from baseline in the LS and TH BMD was significantly greater for the romosozumab group vs the placebo group (LS, 12.1% vs 1.2%; TH, 2.5% vs -0.5%; P < 0.001) in 245 subjects (163 romosozumab, 82 placebo).
• Findings showed that adverse events (AEs) and serious AEs were balanced between the two groups, with a numerical imbalance in the positively adjudicated cardiovascular serious AEs [romosozumab, 8 (4.9%) vs placebo, 2 (2.5%)].