The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial
Background: Children and young people (CYP) with chronic rheumatic conditions; Juvenile Idiopathic Arthritis, Juvenile Systemic Lupus Erythematosus, Juvenile Dermatomyositis and Juvenile Vasculitis, treated with steroids, have low bone density, increased fracture risk and are likely to have suboptim...
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Elsevier
2019-07-01
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Series: | EClinicalMedicine |
Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537019300975 |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Madeleine Rooney Nick Bishop Joyce Davidson Michael W. Beresford Clarissa Pilkington Janet Mc Donagh Sue Wyatt Janet Gardner-Medwin Rangaraj Satyapal Jacqui Clinch Helen Foster Mark Elliott Rejina Verghis |
spellingShingle |
Madeleine Rooney Nick Bishop Joyce Davidson Michael W. Beresford Clarissa Pilkington Janet Mc Donagh Sue Wyatt Janet Gardner-Medwin Rangaraj Satyapal Jacqui Clinch Helen Foster Mark Elliott Rejina Verghis The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial EClinicalMedicine |
author_facet |
Madeleine Rooney Nick Bishop Joyce Davidson Michael W. Beresford Clarissa Pilkington Janet Mc Donagh Sue Wyatt Janet Gardner-Medwin Rangaraj Satyapal Jacqui Clinch Helen Foster Mark Elliott Rejina Verghis |
author_sort |
Madeleine Rooney |
title |
The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial |
title_short |
The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial |
title_full |
The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial |
title_fullStr |
The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial |
title_full_unstemmed |
The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial |
title_sort |
prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: a randomised double-blind controlled trial |
publisher |
Elsevier |
series |
EClinicalMedicine |
issn |
2589-5370 |
publishDate |
2019-07-01 |
description |
Background: Children and young people (CYP) with chronic rheumatic conditions; Juvenile Idiopathic Arthritis, Juvenile Systemic Lupus Erythematosus, Juvenile Dermatomyositis and Juvenile Vasculitis, treated with steroids, have low bone density, increased fracture risk and are likely to have suboptimal peak bone mass. There is currently no evidence base for the management of steroid-induced bone loss in children with rheumatic diseases. Methods: We undertook a multi-centre double dummy double-blind randomised placebo controlled trial to investigate whether the bisphosphonate risedronate was superior to alfacalcidol or calcium and vitamin D supplementation in the prevention and treatment of steroid-induced osteopaenia in these children. Patients were stratified and randomised in a 1:1 ratio, into: placebo; alfacalcidol; risedronate. The primary outcome was the change in lumbar spine bone mineral density z score (LSaBMDz) measured by dual energy x-ray absorptiometry at one year. Secondary outcome was fracture rate. Results: Two hundred and seventeen patients were recruited to the study. Seventy seven placebo, 71 alfacalcidol, and 69 risedronate. Highly statistically significant differences were observed in the change in LSaBMDz between the placebo and risedronate groups; 0.274, 95% CI (0.061, 0.487) (p < 0.001) and between the risedronate and the alfacalcidol groups; 0.326 95% CI (0.109, 0.543) (p < 0.001). The difference observed between the alfacalcidol and placebo group was not statistically significant.Highly statistically significant differences were seen in the change in Total Body Less Head aBMD-Z Score between the placebo and risedronate groups (p < 0.01) but not between the alfacalcidol and risedronate groups. No significant differences in fracture frequency, adverse or serious adverse reactions were observed between the groups. Conclusions: Children and adolescents receiving steroids for rheumatic diseases benefit from prophylactic treatment with bisphosphonates to increase LSaBMD. Alfacalcidol is ineffective. Keywords: Juvenile idiopathic arthritis, Steroids, Osteoporosis, Bisphosphonates, Clinical trial |
url |
http://www.sciencedirect.com/science/article/pii/S2589537019300975 |
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doaj-dc82725413df410e918230d7d54ac85e2020-11-25T00:49:03ZengElsevierEClinicalMedicine2589-53702019-07-01127987The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trialMadeleine Rooney0Nick Bishop1Joyce Davidson2Michael W. Beresford3Clarissa Pilkington4Janet Mc Donagh5Sue Wyatt6Janet Gardner-Medwin7Rangaraj Satyapal8Jacqui Clinch9Helen Foster10Mark Elliott11Rejina Verghis12Queens University of Belfast and Musgrave Park Hospital Belfast Hospital Trust, United Kingdom of Great Britain and Northern Ireland; Corresponding author at: The Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom of Great Britain and Northern Ireland.University of Sheffield and Sheffield Children's NHS Foundation Trust, United Kingdom of Great Britain and Northern IrelandRoyal Edinburgh Hospital for Sick Children, United Kingdom of Great Britain and Northern IrelandClinical Academic Department of Paediatric Rheumatology, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom of Great Britain and Northern IrelandGreat Ormond Street Hospital London, United Kingdom of Great Britain and Northern IrelandBirmingham Children's Hospital NHS, University of Manchester, United Kingdom of Great Britain and Northern IrelandLeeds General Infirmary, United Kingdom of Great Britain and Northern IrelandUniversity of Glasgow and Royal Hospital for Children, Glasgow, United Kingdom of Great Britain and Northern IrelandNottingham University Hospital, United Kingdom of Great Britain and Northern IrelandRoyal Bristol Hospital for Sick Children, United Kingdom of Great Britain and Northern IrelandNewcastle University and Great North Children's Hospital, Newcastle, United Kingdom of Great Britain and Northern IrelandBelfast Hospital Trust, United Kingdom of Great Britain and Northern IrelandNI Clinical Trials Unit, United Kingdom of Great Britain and Northern IrelandBackground: Children and young people (CYP) with chronic rheumatic conditions; Juvenile Idiopathic Arthritis, Juvenile Systemic Lupus Erythematosus, Juvenile Dermatomyositis and Juvenile Vasculitis, treated with steroids, have low bone density, increased fracture risk and are likely to have suboptimal peak bone mass. There is currently no evidence base for the management of steroid-induced bone loss in children with rheumatic diseases. Methods: We undertook a multi-centre double dummy double-blind randomised placebo controlled trial to investigate whether the bisphosphonate risedronate was superior to alfacalcidol or calcium and vitamin D supplementation in the prevention and treatment of steroid-induced osteopaenia in these children. Patients were stratified and randomised in a 1:1 ratio, into: placebo; alfacalcidol; risedronate. The primary outcome was the change in lumbar spine bone mineral density z score (LSaBMDz) measured by dual energy x-ray absorptiometry at one year. Secondary outcome was fracture rate. Results: Two hundred and seventeen patients were recruited to the study. Seventy seven placebo, 71 alfacalcidol, and 69 risedronate. Highly statistically significant differences were observed in the change in LSaBMDz between the placebo and risedronate groups; 0.274, 95% CI (0.061, 0.487) (p < 0.001) and between the risedronate and the alfacalcidol groups; 0.326 95% CI (0.109, 0.543) (p < 0.001). The difference observed between the alfacalcidol and placebo group was not statistically significant.Highly statistically significant differences were seen in the change in Total Body Less Head aBMD-Z Score between the placebo and risedronate groups (p < 0.01) but not between the alfacalcidol and risedronate groups. No significant differences in fracture frequency, adverse or serious adverse reactions were observed between the groups. Conclusions: Children and adolescents receiving steroids for rheumatic diseases benefit from prophylactic treatment with bisphosphonates to increase LSaBMD. Alfacalcidol is ineffective. Keywords: Juvenile idiopathic arthritis, Steroids, Osteoporosis, Bisphosphonates, Clinical trialhttp://www.sciencedirect.com/science/article/pii/S2589537019300975 |