#351 Impact of SGLT2i on bone health in patients with lupus nephritis: randomized double blinded placebo controlled clinical trial

Background and Aims Patients with SLE commonly experience osteoporosis and are at increased risk of bone fractures. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have shown promising cardiovascular and renal benefits in patients with kidney disease, however emerging evidence suggests that they may negatively impact bone health. This study aims to investigate the safety and efficacy of SGLT2i on bone metabolism in patients with lupus nephritis (LN). Method This is a randomized, double-blinded controlled clinical trial, including 84 adult patients with biopsy-proven LN and eGFR > 30 ml/min/1.73 m2. Patients were randomized 1:1 and stratified according to age and gender to Dapagliflozin (10 mg daily) or placebo groups. Serum creatinine, eGFR, urinary protein-creatinine, calcium-creatinine, and phosphorus-creatinine ratios were measured at baseline and after 12 months. Bone health was assessed at the same time points using bone formation markers (bone-specific alkaline phosphatase [BSAP], procollagen type 1 N-terminal propeptide [P1NP]) and bone resorption markers (tartrate-resistant acid phosphatase 5b [TRAP-5b] and Sclerostin). Moreover, Quantitative computed tomography (QCT) was used to assess volumetric bone mineral density (vBMD). Results Participants had a mean age of 38 ± 7 years, with no significant baseline differences between groups. By the end of the study, there were no significant differences in renal function or bone turnover biomarkers between the dapagliflozin and placebo groups after adjusting for baseline values. Only L3 T score of the QCT parameters was significantly lower in the dapagliflozin group compared to the placebo group (P = 0.017). Conclusion Dapagliflozin did not significantly affect bone and mineral metabolism in patients with lupus nephritis over a 12-month period. These findings suggest that dapagliflozin is unlikely to have adverse effects on bone health in patients with lupus nephritis, though further research is warranted to confirm these results over longer periods in a larger cohort.