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P167. Crohn & Bone-study: RCT of risedronate in patients with Crohn's disease and osteopenia [on behalf of the Initiative on Crohn's and Colitis1]

P167. Crohn & Bone-study: RCT of risedronate in patients with Crohn's disease and osteopenia [on behalf of the Initiative on Crohn's and Colitis1]

A.A. van Bodegraven1, P. Lips1, G. Peeters1, P.C.F. Stokkers2, C.J. van der Woude3, G. Dijkstra4, B. Oldenburg5, M. Pierik6, M. Russel7, R. van Hogezand8, L. van de Langerijt9, C. Netelenbos1, D.W. Hommes8

1VU University Medical Centre, Amsterdam, The Netherlands; 2Amsterdam Medical Centre, Amsterdam, The Netherlands; 3Erasmus Medical Centre, Rotterdam, The Netherlands; 4University Medical Centre Groningen, Groningen, The Netherlands; 5University Medical Centre Utrecht, Utrecht, The Netherlands; 6Maastricht University Medical Centre, Maastricht, The Netherlands; 7Medical Centre Twente, Enschede, The Netherlands; 8Leiden University Medical Centre, Leiden, The Netherlands; 9Sanofi Aventis BV, Gouda, The Netherlands

Background: Crohn's disease (CD) is associated with increased bone resorption inducing low bone density and increased fracture risk. To assess the efficacy of bisphosphonates to increase bone density in Crohn's disease associated osteopenia, a prospective, randomized, double-blind trial was conducted with risedronate 35 mg weekly versus placebo. The study was done with patients from clinics of all 8 university hospitals, and one referral hospital in The Netherlands.

Methods: Bone mineral density was assessed by dual energy absorptiometry (DXA) in 123 patients with established CD that was in remission. Patients were between 18–60 years of age and had no recent use of glucucorticoids or bisphosphonates, all were vitamin D sufficient. Crohn's disease Activity Index (CDAI) was calculated, and C-reactive protein was measured to ascertain clinically inactive disease at baseline. DXA was measured at baseline, 12 and 24 months using Hologic densitometers, concomitantly with serum bone markers, and bone fractures at baseline and week 24. Calcium and vitamin D supplements were provided along with risedronate 35 mg or placebo on a weekly basis. CD was evaluated during the 2-years study period. The primary end point of study was the change in BMD, expressed as T-score between baseline and 24 months of treatment.

Results: Baseline demographics included a patient mean age of 42.7 (SD 13.0) yrs, 46% were male, and at inclusion CRP levels and CDAI were 3 mg/L and 86 in the placebo and 4 mg/l and 76 in the risedronate group, respectively. Patients groups with risedronate and placebo were comparable. With respect to the main study outcome we found that DXA in the lumbar spine at baseline had a median score 0.93 (IQR 0.88–1.01) g/cm2, T-score −1.28 (SD 0.77) in the placebo group, and 0.93 (IQR 0.89–1.00), T-score – 1.30 (SD 0.61) in the risedronate group. The median lumbar change at 24 months was 0.01 (IQR −0.02–0.03) g/cm2 in the placebo and 0.03 (IQR 0.00–0.07) in the risedronate group (P = 0.006). The T-score increased at 24 months 0.08 (SD 0.42) in the placebo group and 0.33 (SD 0.46) in the risedronate group (P = 0.005). Changes in BMD of the femur were not significant.

Conclusion: Risedronate improves bone mineral density in CD-patients suffering from CD associated low bone mass by DXA.