PMID- 35195306
OWN - NLM
STAT- MEDLINE
DCOM- 20221118
LR  - 20230103
IS  - 1554-527X (Electronic)
IS  - 0736-0266 (Linking)
VI  - 40
IP  - 12
DP  - 2022 Dec
TI  - Oral Zoledronic acid bisphosphonate for the treatment of chronic low back pain 
      with associated Modic changes: A pilot randomized controlled trial.
PG  - 2924-2936
LID - 10.1002/jor.25304 [doi]
AB  - 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 cm(2) ), 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.
CI  - (c) 2022 Orthopaedic Research Society. Published by Wiley Periodicals LLC.
FAU - Shea, Graham K H
AU  - Shea GKH
AD  - Department of Orthopaedics and Traumatology, The University of Hong Kong, 
      Pokfulam, China.
FAU - Zhang, Changmeng
AU  - Zhang C
AD  - Department of Orthopaedics and Traumatology, The University of Hong Kong, 
      Pokfulam, China.
FAU - Suen, Wai S
AU  - Suen WS
AD  - Department of Orthopaedics and Traumatology, The University of Hong Kong, 
      Pokfulam, China.
FAU - Cheung, Prudence W H
AU  - Cheung PWH
AD  - Department of Orthopaedics and Traumatology, The University of Hong Kong, 
      Pokfulam, China.
FAU - Cheung, Jason P Y
AU  - Cheung JPY
AUID- ORCID: 0000-0002-7052-0875
AD  - Department of Orthopaedics and Traumatology, The University of Hong Kong, 
      Pokfulam, China.
FAU - Maatta, Juhani
AU  - Maatta J
AD  - Medical Research Center Oulu, Oulu University Hospital and University of Oulu, 
      Oulu, Finland.
FAU - Karppinen, Jaro
AU  - Karppinen J
AD  - Medical Research Center Oulu, Oulu University Hospital and University of Oulu, 
      Oulu, Finland.
AD  - Center for Life Course Health Research, University of Oulu, Oulu, Finland.
AD  - Finnish Institute of Occupational Health, Oulu, Finland.
FAU - Samartzis, Dino
AU  - Samartzis D
AUID- ORCID: 0000-0002-7473-1311
AD  - Department of Orthopedic Surgery, Rush University Medical Center, Chicago, 
      Illinois, USA.
AD  - International Spine Research Innovation Initiative, Rush University Medical 
      Center, Chicago, Illinois, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220306
PL  - United States
TA  - J Orthop Res
JT  - Journal of orthopaedic research : official publication of the Orthopaedic 
      Research Society
JID - 8404726
RN  - 6XC1PAD3KF (Zoledronic Acid)
RN  - 0 (Diphosphonates)
SB  - IM
MH  - Humans
MH  - *Low Back Pain/drug therapy
MH  - Zoledronic Acid/pharmacology
MH  - Diphosphonates/therapeutic use/pharmacology
MH  - Lumbar Vertebrae
MH  - Pilot Projects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Modic
OT  - Zoledronic acid
OT  - bisphosphonate
OT  - disc degeneration
OT  - low back pain
OT  - randomized
EDAT- 2022/02/24 06:00
MHDA- 2022/11/19 06:00
CRDT- 2022/02/23 08:43
PHST- 2022/02/13 00:00 [revised]
PHST- 2021/09/18 00:00 [received]
PHST- 2022/02/21 00:00 [accepted]
PHST- 2022/02/24 06:00 [pubmed]
PHST- 2022/11/19 06:00 [medline]
PHST- 2022/02/23 08:43 [entrez]
AID - 10.1002/jor.25304 [doi]
PST - ppublish
SO  - J Orthop Res. 2022 Dec;40(12):2924-2936. doi: 10.1002/jor.25304. Epub 2022 Mar 6.