MON-789 - Effect of Denosumab Therapy in Men with Osteoporosis: Real-World Evidence from A Retrospective Single-Centre Study (PART 4)

Background: Evidence on denosumab use in men with osteoporosis remains limited, particularly in routine clinical practice.

Objective: To evaluate the effects of denosumab therapy on bone mineral density (BMD), fracture incidence, and selected biochemical parameters in men with osteoporosis.

Methods: This single-centre retrospective cohort study included 76 men diagnosed with osteoporosis and treated with denosumab between 2014 and 2025. Demographic and clinical data were extracted from medical records, including age, body mass index, osteoporosis aetiology, prior antiosteoporotic therapy, glucocorticoid exposure, and fracture history. BMD at the lumbar spine (L1–L4) and total hip was assessed using dual-energy X-ray absorptiometry. Serum cholecalciferol, parathyroid hormone (iPTH), and calcium levels were evaluated before and during therapy. Fractures were recorded before and during treatment. Descriptive statistical analysis was performed.

Results: The mean age was 65.7±14.5 years; 75% of patients were ≥60 years old. Denosumab treatment duration ranged from 6 months to 7 years, with 10% treated for ≥5 years. Glucocorticoid-induced osteoporosis was present in 26.3% of patients, while 73.7% had idiopathic osteoporosis. Prior to treatment, fractures were documented in 40.8% of patients, including vertebral fractures in 14.5%. During denosumab therapy, fractures occurred in 5.3% of patients, of which 75% were non-vertebral. Lumbar spine BMD increased by >0.05g/cm² in 42% of patients and remained stable (±0.05g/cm²) in 32%. At the total hip, a clinically relevant BMD increase (>0.05g/cm²) was observed in 79% of patients with paired measurements. The prevalence of cholecalciferol deficiency (≤30ng/mL) decreased from 18.4% before therapy to 4.0% during therapy. Mild PTH elevation was observed in most patients, while serum calcium remained within the normal range in all cases. No major cardiovascular adverse events were recorded during treatment.

Conclusions: In real-world clinical practice, denosumab therapy in men with osteoporosis was associated with improved BMD and a low fracture incidence, supporting its effectiveness and safety in this underrepresented population.

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