title: Intravenous ibandronate or sodium-fluoride--a 3.5 years study on bone density and fractures in Crohn's disease patients with osteoporosis.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: University of Ulm, Department of Internal Medicine I, 89081 Ulm, Germany. jochen.klaus@uniklinik-ulm.de
authors: Jochen
authors: J
authors: Klaus
authors: Max
authors: M
authors: Reinshagen
authors: Katharina
authors: K
authors: Herdt
authors: Guido
authors: G
authors: Adler
authors: Georg B T
authors: GB
authors: von Boyen
authors: Christian
authors: C
authors: von Tirpitz
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019355:Calcium Citrate / Q000008:administration & dosage / Q000009:adverse effects; D002762:Cholecalciferol / Q000008:administration & dosage / Q000009:adverse effects; D003424:Crohn Disease / Q000150:complications*; D003692:Delayed-Action Preparations; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077557:Ibandronic Acid; D015994:Incidence; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000209:etiology; D015995:Prevalence; D012969:Sodium Fluoride / Q000008:administration & dosage* / Q000009:adverse effects; D016103:Spinal Fractures / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D050071:Bone Density Conservation Agents; D003692:Delayed-Action Preparations; D004164:Diphosphonates; D002762:Cholecalciferol; D012969:Sodium Fluoride; D019355:Calcium Citrate; D000077557:Ibandronic Acid