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Effect of Zoledronic Acid and Denosumab in patients with low back pain and modic change: A proof-of-principle trial

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Cai, G, Laslett, LL ORCID: 0000-0002-4336-0095, Aitken, D ORCID: 0000-0001-5685-7634, Halliday, A, Pan, F ORCID: 0000-0002-3403-0094, Otahal, P ORCID: 0000-0003-4042-1769, Speden, D, Winzenberg, TM ORCID: 0000-0002-4112-3491 and Jones, G ORCID: 0000-0002-9814-0006 2018 , 'Effect of Zoledronic Acid and Denosumab in patients with low back pain and modic change: A proof-of-principle trial' , Journal of Bone and Mineral Research , pp. 1-10 , doi: 10.1002/jbmr.3376.

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Abstract

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 randomized to receive ZA (5 mg/100 mL), denosumab (60 mg), 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. A total of 103 participants with moderate/severe LBP (mean VAS = 57 mm; 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 (-22.1 mm2 ; 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.

Item Type: Article
Authors/Creators:Cai, G and Laslett, LL and Aitken, D and Halliday, A and Pan, F and Otahal, P and Speden, D and Winzenberg, TM and Jones, G
Keywords: Bisphosphonate, denosumab, low back pain, modic changes, magnetic resonance imaging
Journal or Publication Title: Journal of Bone and Mineral Research
Publisher: Amer Soc Bone & Mineral Res
ISSN: 0884-0431
DOI / ID Number: 10.1002/jbmr.3376
Copyright Information:

© 2018 American Society for Bone and Mineral Research. This is the peer reviewed version of the following article: Cai, G., Laslett, L. L., Aitken, D., Halliday, A., Pan, F., Otahal, P., Speden, D., Winzenberg, T. M., Jones, G., 2018. Effect of Zoledronic Acid and Denosumab in patients with low back pain and modic change: A proof-of-principle trial, Journal of bone and mineral research, (online first), 1-10., which has been published in final form at http://dx.doi.org/10.1002/jbmr.3376. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.

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