title: Treatment of bone loss in osteopenic patients with Crohn's disease: a double-blind, randomised trial of oral risedronate 35 mg once weekly or placebo, concomitant with calcium and vitamin D supplementation.
abstract: OBJECTIVE
  Osteoporosis and fractures are frequently encountered in patients with Crohn's disease. In order to prevent fractures, treatment with bone protecting drugs appears warranted early in the course of bone disease when bone loss is not yet prominent. We therefore aimed to demonstrate a beneficial effect on bone density of the bisphosphonate risedronate in osteopenic Crohn's disease patients.
  
  
  METHODS
  This double-blind, placebo-controlled randomised trial of risedronate with calcium and vitamin D supplementation was performed in osteopenic Crohn's disease patients. Patients were treated for 2 years with follow-up after 3 and after every 6 months. Disease characteristics and activity and bone turnover markers were assessed at all visits; dual x-ray absorptiometry was performed at baseline, 12 and 24 months; radiographs of the spine at baseline and 24 months.
  
  
  RESULTS
  Of 132 consenting patients, 131 were randomised (67 placebo and 64 risedronate). Patient characteristics were similar in both groups, although the risedronate group was slightly heavier (body mass index 24.3 vs 23.0 kg/m(2)). Bone mineral density at lumbar spine increased 0.04 g/cm(2) on average in the risedronate group versus 0.01 g/cm(2) in the placebo group (p=0.007). The mean increase in total hip bone mineral density was 0.03 versus 0.01 g/cm(2), respectively (p=0.071). Fracture prevalence and incidence were similar. Change of T-scores and concentrations of bone turnover markers were consistent with a beneficial effect of risedronate when compared with placebo. The effect of risedronate was primarily demonstrated in the first 12 months of treatment. No serious unexpected suspected adverse events were observed.
  
  
  CONCLUSIONS
  A 24-month treatment course with risedronate 35 mg once weekly, concomitant with calcium and vitamin D supplementation, in osteopenic Crohn's disease patients improved bone density at lumbar spine. NTR 163 Dutch Trial Register.
authors.affiliation: Department of Gastroenterology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Ad A
authors.initials: AA
authors.lastname: van Bodegraven
authors.affiliation: Department of Internal Medicine, Endocrine Section, MOVE Research Institute, VU University Medical Center, Amsterdam, The Netherlands Department of Clinical Chemistry, MOVE Research Institute, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Bravenboer
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Birgit I
authors.initials: BI
authors.lastname: Witte
authors.affiliation: Department of Gastroenterology, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Gerard
authors.initials: G
authors.lastname: Dijkstra
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: C Janneke
authors.initials: CJ
authors.lastname: van der Woude
authors.affiliation: Department of Gastroenterology, St Lucas Andreas Hospital, Amsterdam, The Netherlands Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Pieter C M
authors.initials: PC
authors.lastname: Stokkers
authors.affiliation: Department of Gastroenterology, Medical Spectrum Twente, Enschede, The Netherlands.
authors.forename: Maurice G
authors.initials: MG
authors.lastname: Russel
authors.affiliation: Department of Gastroenterology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Bas
authors.initials: B
authors.lastname: Oldenburg
authors.affiliation: Department of Gastroenterology, Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: Marieke
authors.initials: M
authors.lastname: Pierik
authors.affiliation: Department of Nuclear Medicine and Radiology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Jan C
authors.initials: JC
authors.lastname: Roos
authors.affiliation: Department of Gastroenterology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Ruud A
authors.initials: RA
authors.lastname: van Hogezand
authors.affiliation: Department of Gastroenterology, VU University Medical Center, Amsterdam, The Netherlands Department of Gastroenterology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Vincent K
authors.initials: VK
authors.lastname: Dik
authors.affiliation: Department of Internal Medicine, Endocrine Section, MOVE Research Institute, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Angela E
authors.initials: AE
authors.lastname: Oostlander
authors.affiliation: Department of Internal Medicine, Endocrine Section, MOVE Research Institute, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: J Coen
authors.initials: JC
authors.lastname: Netelenbos
authors.affiliation: Sanofi-Aventis, Gouda, The Netherlands.
authors.forename: Lex
authors.initials: L
authors.lastname: van de Langerijt
authors.affiliation: Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands Department of Gastroenterology, Leiden University Medical Center, Leiden, The Netherlands Department of Gastroenterology, UCLA Health System, Los Angeles, California, USA.
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Hommes
authors.affiliation: Department of Internal Medicine, Endocrine Section, MOVE Research Institute, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Paul
authors.initials: P
authors.lastname: Lips
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001851:Bone Diseases, Metabolic / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D002118:Calcium / Q000627:therapeutic use*; D003424:Crohn Disease / Q000150:complications*; D019587:Dietary Supplements; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000068296:Risedronic Acid; D016896:Treatment Outcome; D014807:Vitamin D / Q000627:therapeutic use*
chemical_list: D050071:Bone Density Conservation Agents; D014807:Vitamin D; D000068296:Risedronic Acid; D012968:Etidronic Acid; D002118:Calcium
keywords: BONE DISEASE; BONE MINERAL DENSITY; CLINICAL TRIALS; CROHN'S DISEASE; OSTEOPOROSIS