Impact of Prior Treatment and Predictive Factors in Sequential Romosozumab-Denosumab Therapy for Severe Osteoporosis.

PURPOSE: Sequential therapy with romosozumab followed by denosumab is used in patients with severe osteoporosis, but predictive factors for bone mineral density (BMD) response remain unclear.

MATERIALS AND

METHODS

This multicenter retrospective observational study included patients who received 12 monthly romosozumab injections followed by denosumab. Linear mixed-effects models were applied for longitudinal BMD analysis. Fracture incidence was assessed as a secondary endpoint. Both univariable and multivariable analyses were performed, and variance inflation factors were evaluated to ensure model reliability.

RESULTS

Baseline BMD, prior osteoporosis treatment, and nutritional status (as reflected by total lymphocyte count) were identified as significant predictors of BMD response. Within the switched group, patients previously treated with bisphosphonates and those previously treated with denosumab showed heterogeneous responses. Eight fractures occurred during follow-up (one in the treatment-naïve group and seven in the switched group), although this difference did not reach statistical significance.

CONCLUSION

Baseline skeletal status, prior treatment history, and nutritional or metabolic status may influence the BMD response to sequential romosozumab-denosumab therapy. These findings may help inform more individualized treatment strategies in clinical practice.