Ad A van Bodegraven1, Nathalie Bravenboer2, Birgit I Witte3, Gerard Dijkstra4, C Janneke van der Woude5, Pieter C M Stokkers6, Maurice G Russel7, Bas Oldenburg8, Marieke Pierik9, Jan C Roos10, Ruud A van Hogezand11, Vincent K Dik12, Angela E Oostlander13, J Coen Netelenbos13, Lex van de Langerijt14, Daniel W Hommes15, Paul Lips13. 1. Department of Gastroenterology, VU University Medical Center, Amsterdam, The Netherlands. 2. 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. 3. Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands. 4. Department of Gastroenterology, University Medical Center Groningen, Groningen, The Netherlands. 5. Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, The Netherlands. 6. Department of Gastroenterology, St Lucas Andreas Hospital, Amsterdam, The Netherlands Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands. 7. Department of Gastroenterology, Medical Spectrum Twente, Enschede, The Netherlands. 8. Department of Gastroenterology, University Medical Center Utrecht, Utrecht, The Netherlands. 9. Department of Gastroenterology, Maastricht University Medical Center, Maastricht, The Netherlands. 10. Department of Nuclear Medicine and Radiology, VU University Medical Center, Amsterdam, The Netherlands. 11. Department of Gastroenterology, Leiden University Medical Center, Leiden, The Netherlands. 12. Department of Gastroenterology, VU University Medical Center, Amsterdam, The Netherlands Department of Gastroenterology, University Medical Center Utrecht, Utrecht, The Netherlands. 13. Department of Internal Medicine, Endocrine Section, MOVE Research Institute, VU University Medical Center, Amsterdam, The Netherlands. 14. Sanofi-Aventis, Gouda, The Netherlands. 15. 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.
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 (67placebo 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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
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 bisphosphonaterisedronate in osteopenic Crohn's diseasepatients. METHODS: This double-blind, placebo-controlled randomised trial of risedronate with calcium and vitamin D supplementation was performed in osteopenic Crohn's diseasepatients. 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 diseasepatients improved bone density at lumbar spine. NTR 163 Dutch Trial Register. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Entities:
Keywords:
BONE DISEASE; BONE MINERAL DENSITY; CLINICAL TRIALS; CROHN'S DISEASE; OSTEOPOROSIS
Authors: Michał Łodyga; Piotr Eder; Magdalena Gawron-Kiszka; Agnieszka Dobrowolska; Maciej Gonciarz; Marek Hartleb; Maria Kłopocka; Ewa Małecka-Wojciesko; Piotr Radwan; Jarosław Reguła; Edyta Zagórowicz; Grażyna Rydzewska Journal: Prz Gastroenterol Date: 2021-11-19