Original articlesBone mineral density in relation to efficacy and side effects of budesonide and prednisolone in Crohn’s disease
Section snippets
Materials and methods
An open, randomized, controlled trial was conducted in 34 centers in 8 European countries and Israel to compare budesonide CR capsules with oral prednisolone in patients with ileocecal Crohn’s disease. The primary aim of the study was to compare the changes in bone mineral density (BMD) between the 2 treatment modalities (also assessing lumbar spine fractures). In parallel, efficacy of the treatments and its safety and tolerability were assessed as secondary end points to balance clinically
Results
In total, 285 patients were randomized, of whom 272 received at least one dose of study drug and were analyzed (Figure 1). The efficacy analysis is based on 271 patients, because 1 patient did not have any “on treatment” data. Similar proportions of patients in both treatment arms remained in the study (at 6 months, budesonide 81% vs prednisolone 83%; at 12 months, budesonide 61% vs prednisolone 61%; at 24 months, budesonide 52% vs prednisolone 48%). Most withdrawals were the result of
Discussion
It has previously been shown that, at diagnosis, BMD in patients with Crohn’s disease is similar to that of the general population.32 The development of osteopenia, frequently seen at a later stage, could be a consequence of the disease itself or its treatment. The present study intended to explore whether topically acting glucocorticosteroids had advantages over prednisolone with respect to degradation of the bone matrix, with the condition that clinical efficacy should be comparable.
During
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Cited by (0)
The study was performed in scientific collaboration with AstraZeneca Research and Development, Lund, Sweden, and financially supported by AstraZeneca Sweden. Dr Persson has been a full-time employee of AstraZeneca since 1982. Dr Hapten-White is a full-time employee of AstraZeneca. Dr Graffner is an employee of AstraZeneca. Dr Bianchi Porro has received financial support from AstraZeneca.
Members of the MATRIX Study Group are listed in the Appendix.