Long-term treatment with denosumab in patients with celiac disease and osteoporosis at high risk of fracture: a retrospective study.

Patients with celiac disease have lower bone mineral density (BMD) and higher incidence of fractures compared to age- and sex-matched controls. There are no studies of denosumab, an antiresorptive drug, which is a fully human monoclonal antibody that binds the receptor activator of NFκB ligand (RANKL) in celiac patients with osteoporosis. The aim is to study the long-term effect of denosumab on BMD in celiac patients with osteoporosis on a gluten-free diet (GFD), compared to non-celiac osteoporotic patients. Fifteen celiac patients with osteoporosis and control subjects of the same age, sex, BMI, and fragility fractures were enrolled. At baseline, each patient underwent biochemical tests, spine X-ray, and DXA measurements, and the Charlson Comorbidity Index (CCI) was computed. At each visit (every 2 years ± 6 months), with a follow-up of 4 years, any adverse events or new clinical fractures, DXA measurements, and CCI were recorded. In celiac patients, a statistically significant median delta increase in total hip T-score of 0.11 compared to baseline was observed (ANOVA p< 0.05), while in the control group, it was 0.07 (ANOVA p < 0.05), with no difference between groups. New fractures occurred in the celiac group in five patients during the follow-up, and in two patients in the control group (p = 0.38). No adverse events occurred during follow-up. In celiac patients with osteoporosis on GFD, denosumab, with up to 4 years of follow-up, increased hip BMD without adverse events.