Brief Article
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World J Gastroenterol. Jan 21, 2011; 17(3): 334-342
Published online Jan 21, 2011. doi: 10.3748/wjg.v17.i3.334
Bones and Crohn’s: No benefit of adding sodium fluoride or ibandronate to calcium and vitamin D
Jochen Klaus, Max Reinshagen, Katharina Herdt, Christoph Schröter, Guido Adler, Georg BT von Boyen, Christian von Tirpitz
Jochen Klaus, Katharina Herdt, Christoph Schröter, Guido Adler, Georg BT von Boyen, Department of Internal Medicine I, University of Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany
Max Reinshagen, Department of Internal Medicine I, Städtisches Klinikum Braunschweig, Salzdahlumer Straße 90, 38126 Braunschweig, Germany
Christian von Tirpitz, Medizinische Klinik, Kreisklinik Biberach, Ziegelhausstraße 50, 88400 Biberach, Germany
Author contributions: Klaus J and von Tirpitz C contributed equally to this work; Klaus J, Reinshagen M and von Tirpitz C designed the research, and wrote the paper; Klaus J, Reinshagen M, Adler G, von Boyen GBT and von Tirpitz C performed the research; Klaus J, Herdt K, Schröter C and von Tirpitz C analyzed the data.
Correspondence to: Jochen Klaus, MD, Department of Internal Medicine I, University of Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany. jochen.klaus@uniklinik-ulm.de
Telephone: +49-731-50044727 Fax: +49-731-50044610
Received: August 21, 2010
Revised: October 15, 2010
Accepted: October 22, 2010
Published online: January 21, 2011
Abstract

AIM: To compare the effect of calcium and cholecalciferol alone and along with additional sodium fluoride or ibandronate on bone mineral density (BMD) and fractures in patients with Crohn’s disease (CD).

METHODS: Patients (n =148) with reduced BMD (T-score < -1) were randomized to receive cholecalciferol (1000 IU) and calcium citrate (800 mg) daily alone(group A, n = 32) or along with additional sodium fluoride (25 mg bid) (group B, n = 62) or additional ibandronate (1 mg iv/3-monthly) (group C, n = 54). Dual energy X-ray absorptiometry of the lumbar spine (L1-L4) and proximal right femur and X-rays of the spine were performed at baseline and after 1.0, 2.25 and 3.5 years. Fracture-assessment included visual reading of X-rays and quantitative morphometry of vertebral bodies (T4-L4).

RESULTS: One hundred and twenty three (83.1%) patients completed the first year for intention-to-treat (ITT) analysis. Ninety two (62.2%) patients completed the second year and 71 (47.8%) the third year available for per-protocol (PP) analysis. With a significant increase in T-score of the lumbar spine by +0.28 ± 0.35 [95% confidence interval (CI): 0.162-0.460, P < 0.01], +0.33 ± 0.49 (95% CI: 0.109-0.558, P < 0.01), +0.43 ± 0.47 (95% CI: 0.147-0.708, P < 0.01) in group A, +0.22 ± 0.33 (95% CI: 0.125-0.321, P < 0.01); +0.47 ± 0.60 (95% CI: 0.262-0.676, P < 0.01), +0.51 ± 0.44 (95% CI: 0.338-0.682, P < 0.01) in group B and +0.22 ± 0.38 (95% CI: 0.111-0.329, P < 0.01), +0.36 ± 0.53 (95% CI: 0.147-0.578, P < 0.01), +0.41 ± 0.48 (95% CI: 0.238-0.576, P < 0.01) in group C, respectively, during the 1.0, 2.25 and 3.5 year periods (PP analysis), no treatment regimen was superior in any in- or between-group analyses. In the ITT analysis, similar results in all in- and between-group analyses with a significant in-group but non-significant between-group increase in T-score of the lumbar spine by 0.38 ± 0.46 (group A, P < 0.01), 0.37 ± 0.50 (group B, P < 0.01) and 0.35 ± 0.49 (group C, P < 0.01) was observed. Follow-up in ITT analysis was still 2.65 years. One vertebral fracture in the sodium fluoride group was detected. Study medication was safe and well tolerated.

CONCLUSION: Additional sodium fluoride or ibandronate had no benefit over calcium and cholecalciferol alone in managing reduced BMD in CD.

Keywords: Crohn’s disease; Bone mineral density; Vertebral fracture; Cholecalciferol; Calcium; Ibandronate; Sodium fluoride