123820 - Effect of Zoledronic Acid and Denosumab in patients_CC.pdf (256.18 kB)
Effect of Zoledronic Acid and Denosumab in patients with low back pain and modic change: A proof-of-principle trial
journal contribution
posted on 2023-05-19, 15:17 authored by Guoqi CaiGuoqi Cai, Laura LaslettLaura Laslett, Dawn AitkenDawn Aitken, Halliday, A, Feng PanFeng Pan, Petr OtahalPetr Otahal, Speden, D, Tania WinzenbergTania Winzenberg, Graeme JonesGraeme JonesThe 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.
History
Publication title
Journal of Bone and Mineral ResearchVolume
33Issue
5Pagination
773-782ISSN
0884-0431Department/School
Menzies Institute for Medical ResearchPublisher
Amer Soc Bone & Mineral ResPlace of publication
2025 M St, N W, Ste 800, Washington, USA, Dc, 20036-3309Rights statement
© 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.Repository Status
- Open