Long term treatment with denosumab in patients with celiac disease and osteoporosis: a pilot study

Background 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 with 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. Aims To study the long-term effect of denosumab on BMD in celiac patients with osteoporosis on gluten free diet (GFD), compared to non-celiac osteoporotic patients. Methods 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, DXA measurements and the Charlson Comorbidity Index (CCI) was computed. At each visit (every 2 years ± 6 months), with a follow-up of four years, any adverse events or new clinical fractures, DXA measurements and CCI were recorded. Results In celiac patients a statistically significant delta increase in total hip T-score of 0. 15 ± 0.18 compared to baseline was observed (ANOVA p < 0.05), while in the control group of 0.09 ± 0.10 (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. Conclusion In celiac patients with osteoporosis on GFD, denosumab, up to four years of follow-up, increased hip BMD without adverse events.