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Papers of the Week

Papers: 19 Feb 2022 - 25 Feb 2022

Pharmacology/Drug Development

2022 Feb 23

J Orthop Res

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


Shea G K H, Zhang C, Suen W S, Cheung P W H, Cheung J P Y, Maatta J, Karppinen J, Samartzis D
J Orthop Res. 2022 Feb 23.
PMID: 35195306.


To assess the safety and efficacy of oral 50mg 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 cm ), 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. This article is protected by copyright. All rights reserved.