A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis.

Lewiecki, E Michael; Blicharski, Tomasz; Goemaere, Stefan; Lippuner, Kurt; Meisner, Paul D; Miller, Paul D; Miyauchi, Akimitsu; Maddox, Judy; Chen, Li; Horlait, Stephane (2018). A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. The journal of clinical endocrinology and metabolism, 103(9), pp. 3183-3193. Oxford University Press 10.1210/jc.2017-02163

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Orthopaedic, Plastic and Hand Surgery (DOPH) > Clinic of Osteoporosis

UniBE Contributor:

Lippuner, Kurt

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1945-7197

Publisher:

Oxford University Press

Language:

English

Submitter:

Romain Perrelet

Date Deposited:

27 Dec 2018 15:18

Last Modified:

14 Dec 2019 19:36

Publisher DOI:

10.1210/jc.2017-02163

PubMed ID:

29931216

BORIS DOI:

10.7892/boris.122232

URI:

https://boris.unibe.ch/id/eprint/122232

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