Long-Term Oral Budesonide Use in Inflammatory Bowel Disease: Effects on Bone Mineral Density and Late-Onset Adverse Events.

Background/Objectives: Budesonide is a corticosteroid with low systemic bioavailability, commonly used for localized treatment in inflammatory bowel disease (IBD). While its short-term safety is well established, data on long-term effects-particularly regarding bone mineral density (BMD)-are limited. This study assessed the impact of prolonged oral budesonide use on BMD and related adverse events (AEs) in IBD patients. Methods: We retrospectively reviewed IBD patients treated with budesonide for ≥24 months who underwent baseline and follow-up DEXA scans. A matched control group with no history of budesonide use was selected. Clinical and biochemical data, along with DEXA scans, were collected. Changes in BMD of the femur and lumbar spine and BMD status (osteoporosis/osteopenia) were compared between the groups. Results: A total of 52 budesonide-treated patients (6 with ulcerative colitis and 46 with Crohn's disease) and 52 matched controls were included. The mean disease duration of the budesonide group and the control group was 8.8 years and 9 years, respectively. Mean budesonide treatment duration was 46.1 ± 15.4 months (range: 25-94). No significant differences were observed between the control and treatment groups when the last BMD status was compared with the initial assessment. While femoral BMD remained stable in the budesonide group, it significantly declined in the control group (p = 0.019). L1-L4 BMD improved in the budesonide group (p = 0.002). The osteoporosis rate remained unchanged (OR: 0.136, 95% CI: 0.007-2.73, p = 0.19), while osteopenia decreased, favoring the budesonide group (OR: 0.197, 95% CI: 0.038-1.018, p = 0.05). No fragility fractures or systemic AEs occurred during follow-up. Conclusions: Long-term oral budesonide use in IBD appears safe with respect to BMD and is not associated with an increased risk of osteoporosis, osteopenia, or previously unrecognized AEs, even with treatment durations of up to four years. The slightly favorable outcome of BMD in IBD patients treated with budesonide needs further verification.