Romosozumab Efficacy in Osteoporosis: Influence of Diabetes and Previous Antiresorptive Therapy: A Single Centre Experience.

Abstract

Background: Romosozumab is an anabolic agent approved for the treatment of severe osteoporosis in postmenopausal women and in men at high risk of fracture. However, real-world data on its effectiveness, particularly in patients with diabetes mellitus (DM) or prior exposure to antiresorptive therapy, remain limited.

Methods: Adult patients (⩾18 years) who received romosozumab between January 2021 and May 2024 and had both baseline and post-treatment dual-energy X-ray absorptiometry (DEXA) scans were included. Bone mineral density (BMD) at the lumbar spine, total hip and femoral neck was assessed before and after 12 months of therapy. Subgroup analyses were undertaken according to diabetes status and previous antiresorptive therapy exposure.

Results: Eighty-seven patients were included (mean age 66.7 ± 13.0 years; 94.3% female). The median percentage increase in lumbar spine BMD was 6.7% (IQR 1.3-12.6), while increases at the total hip and femoral neck were 2.9% (IQR -1.1 to 9.1) and 2.3% (IQR -3.9 to 9.7), respectively. Patients without diabetes demonstrated significantly greater BMD gains than those with diabetes at the lumbar spine (9.9% vs 3.1%; P = .020), total hip (4.1% vs 0.3%; P = .027), and femoral neck (3.9% vs 0.1%; P = .028). Similarly, treatment-naïve patients had greater improvements in total hip BMD compared with those with prior antiresorptive exposure (8.3% vs 2.2%; P = .004).

Conclusion: Romosozumab significantly increased BMD at the lumbar spine, total hip and femoral neck after 12 months of treatment. The response was more pronounced in patients without diabetes and those who were treatment-naïve, suggesting that metabolic status and previous antiresorptive therapy may influence treatment effectiveness. Prospective studies are warranted to evaluate long-term fracture outcomes and the durability of these effects.