University of Oulu

Shea, GKH, Zhang, C, Suen, WS, et al. Oral Zoledronic acid bisphosphonate for the treatment of chronic low back pain with associated Modic changes: a pilot randomized controlled trial. J Orthop Res. 2022; 40: 2924-2936. doi:10.1002/jor.25304

Oral Zoledronic acid bisphosphonate for the treatment of chronic low back pain with associated Modic changes : a pilot randomized controlled trial

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Author: Shea, Graham K. H.1; Zhang, Changmeng1; Suen, Wai S.1;
Organizations: 1Department of Orthopaedics and Traumatology, The University of Hong Kong, Pokfulam, China
2Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland
3Center for Life Course Health Research, University of Oulu, Oulu, Finland
4Finnish Institute of Occupational Health, Oulu, Finland
5Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
6International Spine Research Innovation Initiative, Rush University Medical Center, Chicago, Illinois, USA
Format: article
Version: accepted version
Access: open
Online Access: PDF Full Text (PDF, 0.6 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe2022122173030
Language: English
Published: John Wiley & Sons, 2022
Publish Date: 2022-12-21
Description:

Abstract

To assess the safety and efficacy of oral 50 mg Zoledronic acid (ZA) bisphosphate once-a-week for 6-weeks to placebo among patients with chronic low back pain (cLBP) and Modic changes (MC) on MRI. A parallel, double-blinded randomized controlled study was performed at a single center, consisted of 25 subjects with cLBP and MC that received ZA (n = 13) or placebo (n = 12). Evaluation was at baseline, 2-weeks, 4-weeks, 3-months and 6-months for assessment of LBP/leg pain intensity, disability (Oswestry-Disability-Index: ODI), health-related quality-of-life (RAND-36), and mental component summary scores (MCS). Type 2 MC at baseline (56%) were prevalent. In the ZA group, LBP intensity was lower at 4-weeks in comparison to placebo (5.1 ± 1.9 vs. 6.9 ± 1.8, p = 0.038) (minimal clinically important difference [MCID] = 1.5). LBP intensity reduced at 4-weeks and 3-months in the ZA-treated group in comparison to baseline. Although there was no difference in ODI, subscale RAND-36 metrics for physical function (p = 0.038), energy/fatigue (p = 0.040) and pain (p = 0.003) were improved at 3-months compared to placebo, with moderate significant difference for pain at 6-months (p = 0.051). Correlated MCS scores to baseline also improved at 3-months (p = 0.035) and 6-months (p = 0.028) by 6.9 and 6.8, respectively, (MCID = 3.8). A reduction in MC endplate affected area at 6-month follow-up was noted in the ZA group (−0.67 ± 0.69 cm²), while in the placebo group no change in size was observed (0.0 ± 0.15; p = 0.041). Three subjects withdrew from the study and no long-lasting adverse events. Oral ZA was a safe and effective treatment that reduced MC volume, improved LBP symptoms and quality-of-life measures in cLBP subjects with MCs.

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Series: Journal of orthopaedic research
ISSN: 0736-0266
ISSN-E: 1554-527X
ISSN-L: 0736-0266
Volume: 40
Issue: 12
Pages: 2924 - 2936
DOI: 10.1002/jor.25304
OADOI: https://oadoi.org/10.1002/jor.25304
Type of Publication: A1 Journal article – refereed
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
Subjects:
Funding: This study was funded by the Health and Medical Research Fund of Hong Kong. Dino Samartzis and Graham K. H. Shea were co-PIs that were awarded the grant.
Copyright information: © 2022 Orthopaedic Research Society. Published by Wiley Periodicals LLC. This is the peer reviewed version of the following article: Shea, GKH, Zhang, C, Suen, WS, et al. Oral Zoledronic acid bisphosphonate for the treatment of chronic low back pain with associated Modic changes: a pilot randomized controlled trial. J Orthop Res. 2022; 40: 2924- 2936, which has been published in final form at https://doi.org/10.1002/jor.25304. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited.