Therapie der Osteoporose bei Morbus Crohn - eine randomisierte Langzeitstudie zum Vergleich von Calcium und Vitamin D alleine oder in Kombination mit Natriumfluorid oder Ibandronat
Background: Reduced bone mineral density (BMD) and osteoporosis are frequent in Crohn’s disease (CD). Aim: To asses the long-term effectiveness of calcium and colecalciferol alone or with additional sodium fluoride or ibandronate on BMD and fracture rate in CD patients with reduced BMD. Methods: 214 CD patients with lumbar osteopenia or osteoporosis (T-score < -1) were randomized to receive either colecalciferol (1000 IU) and calcium citrate (800 mg) daily [A] or additional sodium fluoride (2x 25 mg b.d.) [B] or ibandronate (1 mg i.v. every 3 months) [C]. Dual energy X-ray absorptiometry (DXA) of the lumbar spine (L1-L4) and proximal right femur and X-ray examinations of the thoracic and lumbar spine were performed at baseline and after 1.0, 2.25 and 3.5 years. Results: 178 (83.2 %) patients completed the 1st year study period and were available for the intention-to-treat (ITT) analysis. 134 (62.6 %) patients completed the 2nd and 106 (49.5 %) the 3rd year study period, respectively and were available for the per protocol (PP) analysis. T-score of lumbar spine BMD increased significantly in [A] by 0.28/0.33/0.43, in [B] by 0.23/0.55/0.58 and in [C] by 0.25/0.42/0.43 during the 1.0, 2.25 and 3.5 years study period, respectively (PP analysis). In ITT analysis, lumbar spine BMD increased significantly by 0.38 in [A], 0.47 in [B] and 0.39 in [C] during the study period. No treatment regimen was superior regarding increase of lumbar spine BMD. Conclusions: Calcium and colecalciferol administration alone and both additional sodium fluoride or ibandronate are effective in the management of osteopenia and osteoporosis in patients with CD and induce continuous increases in lumbar BMD. With regard to fracture rate, CD patients with low BMD should receive calcium and colecalciferol administration, optionally with bisphosphonates, at least in these patients with prevalent fractures.
Erstellung / Fertigstellung
Normierte SchlagwörterCrohn-Krankheit [GND]
Crohn disease [MeSH]
Vitamin D [MeSH]