Department of Internal Medicine I, University of Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
World J Gastroenterol. 2011 Jan 21;17(3):334-42. doi: 10.3748/wjg.v17.i3.334.
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).
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).
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.
Additional sodium fluoride or ibandronate had no benefit over calcium and cholecalciferol alone in managing reduced BMD in CD.
比较钙和胆钙化醇单独以及联合额外的氟化钠或伊班膦酸盐对克罗恩病（CD）患者的骨密度（BMD）和骨折的影响。
将（n=148）患有低骨密度（T 评分< -1）的患者随机分配，每天接受胆钙化醇（1000IU）和柠檬酸钙（800mg）单独治疗（组 A，n=32）或联合额外的氟化钠（25mg bid）（组 B，n=62）或额外的伊班膦酸盐（1mg iv/3-每月）（组 C，n=54）。在基线和 1.0、2.25 和 3.5 年后，对腰椎（L1-L4）和右侧股骨近端进行双能 X 射线吸收测定法（DXA）和脊柱 X 射线检查。骨折评估包括 X 射线的视觉阅读和椎体（T4-L4）的定量形态测量。
123 名（83.1%）患者完成了意向治疗（ITT）分析的第一年。92 名（62.2%）患者完成了第二年的分析，71 名（47.8%）患者完成了第三年的分析。腰椎 T 评分显著增加，组 A 分别为+0.28 ± 0.35 [95%置信区间（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）；组 B 分别为+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）；组 C 分别为+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），在 1.0、2.25 和 3.5 年期间（PP 分析），任何治疗方案都没有优势。在 ITT 分析中，所有组内和组间分析都有相似的结果，腰椎 T 评分显著增加，分别为 0.38 ± 0.46（组 A，P < 0.01）、0.37 ± 0.50（组 B，P < 0.01）和 0.35 ± 0.49（组 C，P < 0.01），但组间无显著差异。在 ITT 分析中，随访时间仍为 2.65 年。氟化物组发现 1 例椎体骨折。研究药物安全且耐受良好。
与单独使用钙和胆钙化醇相比，额外的氟化钠或伊班膦酸盐在治疗 CD 患者的低骨密度方面没有益处。
