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Effect of zoledronic acid and denosumab in patients with low back pain and Modic change: a proof of principle trial.

著者 Cai G , Laslett LL , Aitken D , Halliday A , Pan F , Otahal P , Speden D , Winzenberg TM , Jones G
J Bone Miner Res.2018 Jan 03 ; ():.
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The aim of this study was to evaluate the effect of zoledronic acid (ZA) and denosumab on low back pain (LBP) and Modic change (MC) over 6 months. Adults aged ≥40 years with significant LBP for at least 6 months duration and MC (type 1, 2 or mixed) were randomised to receive ZA (5mg/100ml), denosumab (60mg), or placebo. LBP was measured monthly by Visual Analogue Scale (VAS) and the LBP Rating Scale (RS). MC was measured from MRIs of T12-S1 vertebrae at screening and 6 months. 103 participants with moderate/severe LBP (mean VAS=57mm, mean RS=18) and median total MC area 538 mm2 , were enrolled. Compared to placebo, LBP reduced significantly at 6 months in the ZA group for RS (-3.3, 95% CI -5.9 to -0.7) but not VAS (-8.2, 95% CI -18.8 to +2.4) with similar findings for denosumab (RS -3.0, 95% CI -5.7 to -0.3, VAS -10.7, 95% CI -21.7 to +0.2). There was little change in areal MC size overall and no difference between groups with the exception of denosumab in those with type 1 Modic change (-22.1mm2 , 95% CI -41.5 to -2.7). In post-hoc analyses, both medications significantly reduced VAS LBP in participants with milder disc degeneration and non-neuropathic pain, and denosumab reduced VAS LBP in those with type 1 MC over 6 months, compared to placebo. Adverse events were more frequent in the ZA group. These results suggests a potential therapeutic role for ZA and denosumab in MC-associated LBP. This article is protected by copyright. All rights reserved.
PMID: 29297602 [PubMed - as supplied by publisher]
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