Bones and Crohn's: no benefit of adding sodium fluoride or ibandronate to calcium and vitamin D.
OBJECTIVE
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.


CONCLUSIONS
Additional sodium fluoride or ibandronate had no benefit over calcium and cholecalciferol alone in managing reduced BMD in CD.
Department of Internal Medicine I, University of Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany. jochen.klaus@uniklinik-ulm.de
Jochen
J
Klaus
Max
M
Reinshagen
Katharina
K
Herdt
Christoph
C
Schröter
Guido
G
Adler
Georg Bt
GB
von Boyen
Christian
C
von Tirpitz
D015502:Absorptiometry, Photon; D000328:Adult; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use*; D019355:Calcium Citrate / Q000494:pharmacology / Q000627:therapeutic use*; D002762:Cholecalciferol / Q000494:pharmacology / Q000627:therapeutic use; D003424:Crohn Disease / Q000188:drug therapy*; D004164:Diphosphonates / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D050723:Fractures, Bone / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D000077557:Ibandronic Acid; D008297:Male; D008875:Middle Aged; D012969:Sodium Fluoride / Q000494:pharmacology / Q000627:therapeutic use*; D014807:Vitamin D / Q000494:pharmacology / Q000627:therapeutic use*; D055815:Young Adult
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D014807:Vitamin D; D002762:Cholecalciferol; D012969:Sodium Fluoride; D019355:Calcium Citrate; D000077557:Ibandronic Acid
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