University of Ulm, Department of Internal Medicine I, 89081 Ulm, Germany.
J Gastrointestin Liver Dis. 2011 Jun;20(2):141-8.
Osteoporosis commonly afflicts Crohn's disease (CD) patients. Management remains unclear, with limited results for intravenous (i.v.) bisphosphonates and a follow-up longer than one year. Intravenous bisphosphonates bypass gastrointestinal-tract irritation offering an interesting alternative suitable for CD patients. We tested the long-term efficacy and safety of colecalciferol and calcium with sodium-fluoride or i.v. ibandronate for osteoporosis in CD.
66 CD patients with lumbar osteoporosis (T-score<-2.5) were randomized to receive colecalciferol (1000 IU), calcium-citrate (800 mg) and intermittent sustained-release sodium-fluoride (50 mg) [groupA, n=33] or i.v. ibandronate (1 mg/3-monthly) [groupB, n=33]. Dual-energy X-ray absorptiometry of the lumbar-spine and 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 and quantitative morphometry of X-rays.
55 (83.3%) patients completed at least the 1st year available for intention-to-treat (ITT) analysis, 42 (63.6%) completed the 2nd and 35 (53.0%) the 3rd year available for per-protocol analysis. Lumbar T-score increased by +0.23±0.43 (95%CI: 0.057-0.407, p<0.05), +0.71±1.05 (95%CI: 0.193-1.232, p<0.001) and +0.73±0.82 (95%CI: 0.340-1.336, p<0.001) (group A), and +0.28±0.41 (95%CI: 0.132-0.459, p<0.05), +0.43±0.55 (95%CI: 0.184-0.671, p<0.01) and +0.51±0.74 (95%CI: 0.145-0.882, p<0.001) (group B) during 1.0, 2.25 and 3.5 years follow-up time. In 2.71 years of follow-up, with the ITT analysis, the lumbar T-score increased by +0.66±0.97 (group A, p<0.001) and +0.46±0.67 (group B, p<0.001). One vertebral fracture with sodium-fluoride was not enough to detect differences between groups and the study was not powered for this. Study medication was well-tolerated and safe.
Sodium-fluoride and i.v. ibandronate improved osteoporosis. Keeping in mind bisphosphonates as a standard of osteoporosis care that reduce fracture-rate, data we do not have for sodium-fluoride, CD patients with osteoporosis can be treated safely with i.v. ibandronate.
骨质疏松症常影响克罗恩病（CD）患者。管理仍不清楚，静脉（iv）双磷酸盐的结果有限，且随访时间超过一年。静脉双磷酸盐可绕过胃肠道刺激，为 CD 患者提供了一种有趣的替代选择。我们测试了维生素 D 和钙联合或不联合静脉伊班膦酸盐治疗 CD 患者骨质疏松症的长期疗效和安全性。
66 例腰椎骨质疏松症（T 评分<-2.5）的 CD 患者被随机分为接受骨化三醇（1000 IU）、柠檬酸钙（800 mg）和间歇性缓释氟化钠（50 mg）[A 组，n=33]或静脉伊班膦酸盐（1 mg/3 个月）[B 组，n=33]。在基线、1.0、2.25 和 3.5 年后进行腰椎和右股骨的双能 X 射线吸收法和脊柱 X 射线检查。骨折评估包括 X 射线的视觉阅读和定量形态计量学。
55 例（83.3%）患者至少完成了 1 年的意向治疗（ITT）分析，42 例（63.6%）完成了第 2 年，35 例（53.0%）完成了第 3 年的协议分析。腰椎 T 评分增加了+0.23±0.43（95%CI：0.057-0.407，p<0.05），+0.71±1.05（95%CI：0.193-1.232，p<0.001）和+0.73±0.82（95%CI：0.340-1.336，p<0.001）（A 组），和+0.28±0.41（95%CI：0.132-0.459，p<0.05），+0.43±0.55（95%CI：0.184-0.671，p<0.01）和+0.51±0.74（95%CI：0.145-0.882，p<0.001）（B 组）在 1.0、2.25 和 3.5 年的随访时间内。在 2.71 年的随访中，ITT 分析显示，腰椎 T 评分增加了+0.66±0.97（A 组，p<0.001）和+0.46±0.67（B 组，p<0.001）。氟化物组发生了 1 例椎体骨折，但不足以检测出组间差异，而且该研究没有对此进行统计分析。研究药物耐受性良好且安全。
氟化钠和静脉伊班膦酸盐改善了骨质疏松症。考虑到双磷酸盐是降低骨折发生率的骨质疏松症治疗标准，我们没有氟化物的数据，CD 患者的骨质疏松症可以安全地用静脉伊班膦酸盐治疗。
