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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EAlthough glucocorticoids (GCs) are a backbone of the treatment of rheumatic diseases, they are the major cause of secondary osteoporosis and are associated with increased fracture rate and decreased bone quality. This article discusses outcomes from Denosumab in Current Users of Bisphosphonates for Glucocorticoid-Induced Osteoporosis [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01465568\u0026amp;atom=%2Fspmdc%2F14%2F17%2F19.atom\u0022\u003ENCT01465568\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMetabolic Bone Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatoid Arthritis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ELupus Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMetabolic Bone Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatoid Arthritis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ELupus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EAlthough glucocorticoids (GCs) are a backbone of the treatment of rheumatic diseases, they are the major cause of secondary osteoporosis and are associated with increased fracture rate and decreased bone quality. The American College of Rheumatology guidelines for glucocorticoid-induced osteoporosis recommend bisphosphonate (BSP) treatment for most patients receiving high-dose or long-term GC therapy [Grossman JM et al. \u003Cem\u003EArthritis Care Res\u003C\/em\u003E 2010]. Drawbacks of BSPs include adverse events (AEs), poor adherence, and treatment failures, resulting in a need for other agents to prevent and treat osteoporosis. Denosumab is a fully humanized monoclonal antibody against the receptor activator of nuclear factor-kB ligand (RANKL), which is essential for the formation, function, and survival of osteoclasts. Denosumab inhibits osteoclast activity and has been shown to reduce the incidence of hip and spine fractures and to increase hip and spine bone mineral density (BMD) in postmenopausal women [Bone HG et al. \u003Cem\u003EJ Clin Endocrinol Metab\u003C\/em\u003E 2013; Cummings SR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2009]. A subgroup analysis of patients with rheumatoid arthritis (RA) receiving GCs suggested that denosumab increases spine and hip BMD and reduces bone turnover [Dore RK et al. \u003Cem\u003EAnn Rheum Dis\u003C\/em\u003E 2010].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EChi Chiu Mok, MD, Tuen Mun Hospital, Hong Kong, China, reported outcomes from Denosumab in Current Users of Bisphosphonates for Glucocorticoid-Induced Osteoporosis [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01465568\u0026amp;atom=%2Fspmdc%2F14%2F17%2F19.atom\u0022\u003ENCT01465568\u003C\/a\u003E]. This 12-month, open-label, randomized trial conducted at 1 site in China assessed the effects of denosumab on BMD in adults with systemic lupus erythematosus and RA who required long-term prednisolone therapy and who had suboptimal responses to 2 years or more of BSPs. Patients had received long-term prednisolone or equivalent, defined as more than 2.5 mg daily, within 3 months of trial entry. Suboptimal response to BSP was defined as lumbar spine or hip BMD failing to increase by 2% or more, BMD remaining osteoporotic with a \u003Cem\u003Et\u003C\/em\u003E score less than \u22122.5 or z-score less than \u22122.0, or development of new fragility vertebral or nonvertebral fractures during BSP treatment. Patients were randomly assigned to subcutaneous denosumab 60 mg every 6 months instead of BSPs or to continuation of BSPs; 21 patients were assigned to each treatment group, and 20 in each completed 12 months of therapy. There were no significant differences in clinical characteristics between treatment groups.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EPatients receiving denosumab had a significant increase in lumbar spinal BMD, the primary endpoint, compared with the BSP group at 6 months (3.07% vs 0.56%; p=0.047) and at 12 months (3.39% vs 1.48%; p=0.026); these results were adjusted for baseline BMD, duration of disease and calcium and vitamin D use, osteoporosis risk factors, and cumulative dose of prednisolone. There were no significant differences in the secondary end point of changes in hip and femoral neck BMD at 6 and 12 months between treatment groups. No new fractures developed in any patients during the trial. Bone turnover marker assays are ongoing. Denosumab was well tolerated but was associated with increased infections. AEs are summarized in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/14595\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/14595\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/14595\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-5\u0022 class=\u0022first-child\u0022\u003EAdverse Events\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EAlthough 12 months of therapy with denosumab was associated with increased lumbar spine BMD in patients receiving long-term GCs who did not respond to BSP therapy, there were no increases in hip or femoral neck BMD with denosumab. These results should be confirmed in a larger study.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/17\/19.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzp3o1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzp3o1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}