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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
  1. Ad A van Bodegraven1,
  2. Nathalie Bravenboer2,3,
  3. Birgit I Witte4,
  4. Gerard Dijkstra5,
  5. C Janneke van der Woude6,
  6. Pieter C M Stokkers7,8,
  7. Maurice G Russel9,
  8. Bas Oldenburg10,
  9. Marieke Pierik11,
  10. Jan C Roos12,
  11. Ruud A van Hogezand13,
  12. Vincent K Dik1,10,
  13. Angela E Oostlander2,
  14. J Coen Netelenbos2,
  15. Lex van de Langerijt14,
  16. Daniel W Hommes8,13,15,
  17. Paul Lips2,
  18. on behalf of the Dutch Initiative on Crohn and Colitis (ICC)
  1. 1Department of Gastroenterology, VU University Medical Center, Amsterdam, The Netherlands
  2. 2Department of Internal Medicine, Endocrine Section, MOVE Research Institute, VU University Medical Center, Amsterdam, The Netherlands
  3. 3Department of Clinical Chemistry, MOVE Research Institute, VU University Medical Center, Amsterdam, The Netherlands
  4. 4Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands
  5. 5Department of Gastroenterology, University Medical Center Groningen, Groningen, The Netherlands
  6. 6Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, The Netherlands
  7. 7Department of Gastroenterology, St Lucas Andreas Hospital, Amsterdam, The Netherlands
  8. 8Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands
  9. 9Department of Gastroenterology, Medical Spectrum Twente, Enschede, The Netherlands
  10. 10Department of Gastroenterology, University Medical Center Utrecht, Utrecht, The Netherlands
  11. 11Department of Gastroenterology, Maastricht University Medical Center, Maastricht, The Netherlands
  12. 12Department of Nuclear Medicine and Radiology, VU University Medical Center, Amsterdam, The Netherlands
  13. 13Department of Gastroenterology, Leiden University Medical Center, Leiden, The Netherlands
  14. 14Sanofi-Aventis, Gouda, The Netherlands
  15. 15Department of Gastroenterology, UCLA Health System, Los Angeles, California, USA
  1. Correspondence to Dr Ad A van Bodegraven, Department of Gastroenterology, VU University Medical Center, PO Box 7057, Amsterdam 1007 MB, The Netherlands; v.bodegraven{at}vumc.nl

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/m2). Bone mineral density at lumbar spine increased 0.04 g/cm2 on average in the risedronate group versus 0.01 g/cm2 in the placebo group (p=0.007). The mean increase in total hip bone mineral density was 0.03 versus 0.01 g/cm2, 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.

  • BONE DISEASE
  • CLINICAL TRIALS
  • CROHN'S DISEASE
  • OSTEOPOROSIS
  • BONE MINERAL DENSITY

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