摘要
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% conf idence 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.
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% conf idence 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.
关键词
柠檬酸钙
氟化钠
维生素D
双能X射线
膦
骨骼
治疗方案
ITT
Crohn’s disease
Bone mineral density
Vertebral fracture
Cholecalciferol
Calcium
Ibandronate
Sodium fluoride
