A phase III randomized placebo-controlled trial to evaluate efficacy and safety of romosozumab in men with osteoporosis
EM Lewiecki, T Blicharski, S Goemaere… - The Journal of …, 2018 - academic.oup.com
EM Lewiecki, T Blicharski, S Goemaere, K Lippuner, PD Meisner, PD Miller, A Miyauchi…
The Journal of Clinical Endocrinology & Metabolism, 2018•academic.oup.comContext Globally, one in five men aged> 50 years is predicted to experience an osteoporotic
fracture. Because of the treatment gap in osteoporosis and the paucity of bone-forming
agents for men, new osteoporosis treatments are needed. Objective To evaluate the safety
and efficacy of romosozumab in men with osteoporosis. Design Phase III randomized
BRIDGE study (placebo-controlled double-blind study evaluating the efficacy and safety of
romosozumab in treating men with osteoporosis; ClinicalTrials. gov identifier …
fracture. Because of the treatment gap in osteoporosis and the paucity of bone-forming
agents for men, new osteoporosis treatments are needed. Objective To evaluate the safety
and efficacy of romosozumab in men with osteoporosis. Design Phase III randomized
BRIDGE study (placebo-controlled double-blind study evaluating the efficacy and safety of
romosozumab in treating men with osteoporosis; ClinicalTrials. gov identifier …
Context
Globally, one in five men aged >50 years is predicted to experience an osteoporotic fracture. Because of the treatment gap in osteoporosis and the paucity of bone-forming agents for men, new osteoporosis treatments are needed.
Objective
To evaluate the safety and efficacy of romosozumab in men with osteoporosis.
Design
Phase III randomized BRIDGE study (placebo-controlled double-blind study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis; ClinicalTrials.gov identifier, NCT02186171) for 12 months.
Setting
Thirty-one centers in Europe, Latin America, Japan, and North America.
Patients
Men aged 55 to 90 years with a baseline bone mineral density (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.
Interventions
The subjects were randomized 2:1 to receive romosozumab 210 mg subcutaneously monthly or placebo for 12 months.
Main Outcome Measures
The primary efficacy endpoint was percentage change from baseline in LS BMD at month 12.
Results
In 245 subjects (163 romosozumab, 82 placebo), at month 12, the mean percentage change from baseline in the LS and TH BMD was significantly greater for the romosozumab group than for the placebo group (LS, 12.1% vs 1.2%; TH, 2.5% vs −0.5%; P < 0.001). Adverse events and serious adverse events were balanced between the two groups, with a numerical imbalance in the positively adjudicated cardiovascular serious adverse events [romosozumab, 8 (4.9%) vs placebo, 2 (2.5%)].
Conclusions
Treatment with romosozumab for 12 months increased the spine and hip BMD compared with placebo and was well tolerated in men with osteoporosis.
Oxford University Press