Bone mineral density in relation to efficacy and side effects of budesonide and prednisolone in Crohn’s disease

• Published in: Clinical gastroenterology and hepatology Vol. 3; no. 2; pp. 113 - 121
• Main Authors: Schoon, Erik J., Bollani, Simona, Mills, Peter R., Israeli, Eran, Felsenberg, Dieter, Ljunghall, Sverker, Persson, Tore, Haptén-White, Louise, Graffner, Hans, Bianchi Porro, Gabriele, Vatn, Morten, Stockbrügger, Reinhold W.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2005
• Subjects: Administration, Oral; Adult; Aged; Analysis of Variance; BMD; Bone Density - drug effects; bone mineral density; Budesonide - adverse effects; Budesonide - therapeutic use; controlled release; Crohn Disease - diagnosis; Crohn Disease - drug therapy; Dose-Response Relationship, Drug; Drug Administration Schedule; dual-energy x-ray absorptiometry; DXA; Female; Follow-Up Studies; Humans; IBDQ; Incidence; Inflammatory Bowel Disease Questionnaire; Male; Middle Aged; Osteoporosis - chemically induced; Osteoporosis - physiopathology; Prednisolone - adverse effects; Prednisolone - therapeutic use; Probability; Reference Values; Risk Assessment; Severity of Illness Index; SF-36; Short Form 36 questionnaire; Single-Blind Method; BMD; IBDQ; DXA; CR; SF-36
• ISSN: 1542-3565; 1542-7714
• DOI: 10.1016/S1542-3565(04)00662-7

Background & Aims: Osteoporosis frequently occurs in Crohn’s disease, often because of corticosteroids. Budesonide as controlled release capsules is a locally acting corticosteroid with low systemic bioavailability. We investigated its effects on bone compared with prednisolone. Methods: In 34 international centers, 272 patients with Crohn’s disease involving ileum and/or colon ascendens were randomized to once daily treatment with budesonide or prednisolone for 2 years at doses adapted to disease activity. One hundred eighty-one corticosteroid-free patients had active disease (98 had never received corticosteroids, corticosteroid naive; 83 had received corticosteroids previously, corticosteroid exposed), and 90 had quiescent disease, receiving long-term low doses of corticosteroids, corticosteroid-dependent; in 1 patient, no efficacy data were obtained. Bone mineral density and fractures were assessed in a double-blinded fashion; disease activity, side effects, and quality of life were monitored. Results: Neither the corticosteroid-free nor the corticosteroid-dependent patients treated with budesonide differed significantly in bone mineral density from those receiving prednisolone. However, corticosteroid-naive patients receiving budesonide had smaller reductions in bone mineral density than those on prednisolone (mean, −1.04% vs −3.84%; P = .0084). Treatment-emergent corticosteroid side effects were less frequent with budesonide. Efficacy was similar in both groups. Conclusions: Treatment with budesonide is associated with better preserved bone mass compared with prednisolone in only the corticosteroid-naive patients with active ileocecal Crohn’s disease. In both the corticosteroid-free and corticosteroid-dependent groups, budesonide and prednisolone were equally effective for up to 2 years, but budesonide caused fewer corticosteroid side effects.