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Background/aim To evaluate the safety of budesonide in primary biliary cirrhosis. Methods 77 primary biliary cirrhosis patients, with stages I–III at entry, were randomized to use either budesonide 6 mg and ursodeoxycholic acid 15 mg/kg (group A), or ursodeoxycholic acid alone (group B) daily for 3 years. In 22 patients, budesonide pharmacokinetics was determined after 3 years. Bone mass density was measured in 62 patients at baseline and 3 years; in 57 patients also liver biopsies were performed. Results At 3 years, no significant differences in the pharmacokinetics of budesonide were found between the patients with stages 0–I, II and III primary biliary cirrhosis. In group A, bone mass density in femoral neck and lumbar spine were decreased by 3.6% ( P = 0.0002) and 2.8% ( P = 0.003) from the baseline. In group B, the corresponding decreases were 1.9% ( P = 0.029) and 0.7% ( P = 0.25), but the differences between the groups were not statistically significant ( P = 0.16 for femoral neck and P = 0.08 for lumbar spine). Conclusions The plasma concentrations of budesonide do not significantly differ within stages I–III primary biliary cirrhosis patients. The combination of budesonide and ursodeoxycholic acid may decrease bone mass density in the femoral neck and lumbar spine in some primary biliary cirrhosis patients, and bone mass density is recommended to be monitored during budesonide therapy. [ABSTRACT FROM AUTHOR]