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Comparative Effectiveness and Cardiovascular Safety of Romosozumab versus Teriparatide in Osteoporosis Patients with
Cheng-Hsien Hung1,2, Fu-Yu Yang3, Hung-En Huang2,4
1Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
Key Points:
Romosozumab was associated with lower vertebral fracture risk than teriparatide in patients with osteoporosis and CKD. No significant differences were observed in nonvertebral or hip fracture risk between treatment groups. Romosozumab was associated with lower risks of major adverse cardiovascular events and myocardial infarction compared with teriparatide.
Background:
Osteoporosis commonly coexists with CKD, increasing skeletal fragility and cardiovascular risk. While romosozumab shows superior fracture prevention in general osteoporosis, evidence in CKD stages 3-5 patients remains limited.
Methods:
Using a target trial emulation design, we conducted a retrospective cohort study leveraging the TriNetX US research network. Patients aged 40 years or older with osteoporosis and an eGFR<60 ml/min per 1.73 m 2 were included. After 1:1 propensity score matching, outcomes were assessed using Cox proportional hazards models. The primary effectiveness outcomes were nonvertebral and vertebral fractures within 12 months. The secondary outcome was hip fractures. Safety outcomes included major adverse cardiovascular events, myocardial infarction, stroke, and all-cause mortality.
Results:
After propensity score matching, 2045 patients were included in each group. Romosozumab was associated with a significantly lower risk of vertebral fractures compared with teriparatide (hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.42 to 0.98), whereas no significant differences were observed for nonvertebral or hip fractures. For cardiovascular safety, romosozumab was linked to a reduced risk of major adverse cardiovascular events (HR, 0.82; 95% CI, 0.70 to 0.97) and myocardial infarction (HR, 0.77; 95% CI, 0.63 to 0.95). These findings were generally consistent across most subgroups and sensitivity analyses.
Conclusion:
In patients with osteoporosis and CKD, romosozumab was more effective than teriparatide in reducing vertebral fracture risk and was associated with a lower incidence of major cardiovascular events. These findings support the potential dual benefits of romosozumab in this high-risk population and highlight the need for further prospective studies, particularly in those with advanced CKD.