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Article: Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial

TitleZoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial
Authors
Issue Date2009
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
Citation
The Lancet, 2009, v. 373 n. 9671, p. 1253-1263 How to Cite?
AbstractBackground: Persistent use of glucocorticoid drugs is associated with bone loss and increased fracture risk. Concurrent oral bisphosphonates increase bone mineral density and reduce frequency of vertebral fractures, but are associated with poor compliance and adherence. We aimed to assess whether one intravenous infusion of zoledronic acid was non-inferior to daily oral risedronate for prevention and treatment of glucocorticoid-induced osteoporosis. Methods: This 1-year randomised, double-blind, double-dummy, non-inferiority study of 54 centres in 12 European countries, Australia, Hong Kong, Israel, and the USA, tested the effectiveness of 5 mg intravenous infusion of zoledronic acid versus 5 mg oral risedronate for prevention and treatment of glucocorticoid-induced osteoporosis. 833 patients were randomised 1:1 to receive zoledronic acid (n=416) or risedronate (n=417). Patients were stratified by sex, and allocated to prevention or treatment subgroups dependent on duration of glucocorticoid use immediately preceding the study. The treatment subgroup consisted of those treated for more than 3 months (272 patients on zoledronic acid and 273 on risedronate), and the prevention subgroup of those treated for less than 3 months (144 patients on each drug). 62 patients did not complete the study because of adverse events, withdrawal of consent, loss to follow-up, death, misrandomisation, or protocol deviation. The primary endpoint was percentage change from baseline in lumbar spine bone mineral density. Drug efficacy was assessed on a modified intention-to-treat basis and safety was assessed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00100620. Findings: Zoledronic acid was non-inferior and superior to risedronate for increase of lumbar spine bone mineral density in both the treatment (least-squares mean 4·06% [SE 0·28] vs 2·71% [SE 0·28], mean difference 1·36% [95% CI 0·67-2·05], p=0·0001) and prevention (2·60% [0·45] vs 0·64% [0·46], 1·96% [1·04-2·88], p<0·0001) subgroups at 12 months. Adverse events were more frequent in patients given zoledronic acid than in those on risedronate, largely as a result of transient symptoms during the first 3 days after infusion. Serious adverse events were worsening rheumatoid arthritis for the treatment subgroup and pyrexia for the prevention subgroup. Interpretation: A single 5 mg intravenous infusion of zoledronic acid is non-inferior, possibly more effective, and more acceptable to patients than is 5 mg of oral risedronate daily for prevention and treatment of bone loss that is associated with glucocorticoid use. Funding: Novartis Pharma. © 2009 Elsevier Ltd. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/163239
ISSN
2015 Impact Factor: 44.002
2015 SCImago Journal Rankings: 14.638
References

 

DC FieldValueLanguage
dc.contributor.authorReid, DMen_US
dc.contributor.authorDevogelaer, JPen_US
dc.contributor.authorSaag, Ken_US
dc.contributor.authorRoux, Cen_US
dc.contributor.authorLau, CSen_US
dc.contributor.authorReginster, JYen_US
dc.contributor.authorPapanastasiou, Pen_US
dc.contributor.authorFerreira, Aen_US
dc.contributor.authorHartl, Fen_US
dc.contributor.authorFashola, Ten_US
dc.contributor.authorMesenbrink, Pen_US
dc.contributor.authorSambrook, PNen_US
dc.date.accessioned2012-09-05T05:29:03Z-
dc.date.available2012-09-05T05:29:03Z-
dc.date.issued2009en_US
dc.identifier.citationThe Lancet, 2009, v. 373 n. 9671, p. 1253-1263en_US
dc.identifier.issn0140-6736en_US
dc.identifier.urihttp://hdl.handle.net/10722/163239-
dc.description.abstractBackground: Persistent use of glucocorticoid drugs is associated with bone loss and increased fracture risk. Concurrent oral bisphosphonates increase bone mineral density and reduce frequency of vertebral fractures, but are associated with poor compliance and adherence. We aimed to assess whether one intravenous infusion of zoledronic acid was non-inferior to daily oral risedronate for prevention and treatment of glucocorticoid-induced osteoporosis. Methods: This 1-year randomised, double-blind, double-dummy, non-inferiority study of 54 centres in 12 European countries, Australia, Hong Kong, Israel, and the USA, tested the effectiveness of 5 mg intravenous infusion of zoledronic acid versus 5 mg oral risedronate for prevention and treatment of glucocorticoid-induced osteoporosis. 833 patients were randomised 1:1 to receive zoledronic acid (n=416) or risedronate (n=417). Patients were stratified by sex, and allocated to prevention or treatment subgroups dependent on duration of glucocorticoid use immediately preceding the study. The treatment subgroup consisted of those treated for more than 3 months (272 patients on zoledronic acid and 273 on risedronate), and the prevention subgroup of those treated for less than 3 months (144 patients on each drug). 62 patients did not complete the study because of adverse events, withdrawal of consent, loss to follow-up, death, misrandomisation, or protocol deviation. The primary endpoint was percentage change from baseline in lumbar spine bone mineral density. Drug efficacy was assessed on a modified intention-to-treat basis and safety was assessed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00100620. Findings: Zoledronic acid was non-inferior and superior to risedronate for increase of lumbar spine bone mineral density in both the treatment (least-squares mean 4·06% [SE 0·28] vs 2·71% [SE 0·28], mean difference 1·36% [95% CI 0·67-2·05], p=0·0001) and prevention (2·60% [0·45] vs 0·64% [0·46], 1·96% [1·04-2·88], p<0·0001) subgroups at 12 months. Adverse events were more frequent in patients given zoledronic acid than in those on risedronate, largely as a result of transient symptoms during the first 3 days after infusion. Serious adverse events were worsening rheumatoid arthritis for the treatment subgroup and pyrexia for the prevention subgroup. Interpretation: A single 5 mg intravenous infusion of zoledronic acid is non-inferior, possibly more effective, and more acceptable to patients than is 5 mg of oral risedronate daily for prevention and treatment of bone loss that is associated with glucocorticoid use. Funding: Novartis Pharma. © 2009 Elsevier Ltd. All rights reserved.en_US
dc.languageengen_US
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lanceten_US
dc.relation.ispartofThe Lanceten_US
dc.subject.meshAdministration, Oralen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAgeden_US
dc.subject.meshAged, 80 And Overen_US
dc.subject.meshAnalysis Of Varianceen_US
dc.subject.meshBone Density - Drug Effectsen_US
dc.subject.meshBone Density Conservation Agents - Therapeutic Useen_US
dc.subject.meshDiphosphonates - Adverse Effects - Therapeutic Useen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshDrug Administration Scheduleen_US
dc.subject.meshEtidronic Acid - Adverse Effects - Analogs & Derivatives - Therapeutic Useen_US
dc.subject.meshFemaleen_US
dc.subject.meshGlucocorticoids - Adverse Effectsen_US
dc.subject.meshHumansen_US
dc.subject.meshImidazoles - Adverse Effects - Therapeutic Useen_US
dc.subject.meshInfusions, Intravenousen_US
dc.subject.meshLeast-Squares Analysisen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshOsteoporosis - Chemically Induced - Drug Therapyen_US
dc.subject.meshTreatment Outcomeen_US
dc.subject.meshYoung Adulten_US
dc.titleZoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trialen_US
dc.typeArticleen_US
dc.identifier.emailLau, CS:cslau@hku.hken_US
dc.identifier.authorityLau, CS=rp01348en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1016/S0140-6736(09)60250-6en_US
dc.identifier.pmid19362675-
dc.identifier.scopuseid_2-s2.0-64049104797en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-64049104797&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume373en_US
dc.identifier.issue9671en_US
dc.identifier.spage1253en_US
dc.identifier.epage1263en_US
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridReid, DM=35372429900en_US
dc.identifier.scopusauthoridDevogelaer, JP=35271465400en_US
dc.identifier.scopusauthoridSaag, K=35448182000en_US
dc.identifier.scopusauthoridRoux, C=14054986200en_US
dc.identifier.scopusauthoridLau, CS=14035682100en_US
dc.identifier.scopusauthoridReginster, JY=35378176800en_US
dc.identifier.scopusauthoridPapanastasiou, P=36874895000en_US
dc.identifier.scopusauthoridFerreira, A=35733801300en_US
dc.identifier.scopusauthoridHartl, F=7102931080en_US
dc.identifier.scopusauthoridFashola, T=6603044331en_US
dc.identifier.scopusauthoridMesenbrink, P=7801593186en_US
dc.identifier.scopusauthoridSambrook, PN=7103142193en_US
dc.identifier.citeulike6171373-

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