The safety and efficacy of oral Zoledronic acid bisphosphonate for the treatment of chronic low back pain with associated Modic changes: a pilot randomized controlled trial — The International Society for the Study of the Lumbar Spine
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The safety and efficacy of oral Zoledronic acid bisphosphonate for the treatment of chronic low back pain with associated Modic changes: a pilot randomized controlled trial (#1050)

Graham Ka Hon Shea 1 , Changmeng Zhang 1 , Wai Shan Suen 1 , Prudence Wing Hang Cheung 2 , Jason Pui Yin Chueng 3 , Juhani Maatta 4 , Jaro Karppinen 2 , Dino Samartzis 5 6
  1. Department of Orthopaedics and Traumtology, The University of Hong Kong, Pokfulam, Hong Kong
  2. Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu, Finland
  3. Center for Life Course Health Research, University of Oulu, Oulu, Finland
  4. Finnish Institute of Occupational Health, Oulu, Finland
  5. Department of Orthopaedic Surgery, Rush University Medical Center , Chicago, IL, USA
  6. International Spine Research and Innovation Initiative, Rush University Medical Center, Chicago, IL, USA

Introduction: To assess the safety and efficacy of oral 50 mg of Zoledronic acid (ZA), a bisphosphate, once a week for 6 weeks to placebo among patients with chronic low back pain (LBP) and Modic changes (MC) on MRI. 

 

Methods: A parallel, double-blinded randomized controlled study was performed at a single center, consisted of 25 subjects with chronic LBP 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, quality of life, and MC component changes on MRI. 

 

Results: 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). A reduction of LBP intensity at 4 weeks and 3 months in the ZA-treated group in comparison to baseline was noted. 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, whereas the pain domain at 6 months exhibited a trend towards significant difference (p=0.051). A reduction in MC endplate affected area at 6-month follow-up was noted in the ZA group (-0.74±0.67cm2), while in the placebo group an increase in size was observed (+0.42±0.72;p=0.007). Three subjects withdrew from the study. 

 

Discussion: There were no long-lasting adverse events. Oral ZA was a safe and effective treatment that reduced MC affected area, and improved LBP symptoms and health-related quality of life measures in chronic LBP subjects with MCs.

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