Efficacy of annual zoledronic acid in initial percutaneous kyphoplasty patients with osteoporotic vertebral compression fractures: a 3-year follow-up study

Abstract

Summary

This study investigated the efficacy of annual zoledronic acid (ZOL) administration against previously treated recompression vertebral fractures (RVF) and new vertebral fractures (NVF) in initial percutaneous kyphoplasty (PKP) patients with osteoporotic vertebral compression fractures (OVCF) over a 3-year follow-up period.

Introduction

Although PKP achieves a satisfactory outcome, previously treated RVF and NVF can limit its effectiveness. The annual infusion of ZOL over 3 years can improve fracture protection, particularly in the vertebrae. We hypothesized that ZOL can reduce the incidence of RVFs and/or NVFs, and improve the clinical outcomes of PKP.

Methods

This was a placebo-controlled, double-blind prospective trial of 154 PKP patients (mean age: 70 years) with OVCFs. Patients were randomly assigned to receive a single infusion of ZOL (5 mg) or placebo (78 ZOL vs. 76 placebo) at 1 week, 12 months, and 24 months after surgery. Patients were followed-up for 36 months.

Results

ZOL treatment lowered the risk of RVF by ~ 65% over the 36-month period when compared to placebo controls (6.41% in ZOL vs. 18.42% in placebo groups; relative risk, 0.35; 95% CI, 0.13 to 0.92). ZOL also reduced the risk of NVF by ~ 73% (3.85% in ZOL vs. 14.47% in placebo groups; relative risk, 0.27; 95% CI, 0.08 to 0.92). ZOL also significantly reduced the vertebral height lost rate (HLR) at 12, 24, and 36 months. ZOL also improved the visual analog scale (VAS), Oswestry disability index (ODI) scores, and bone mineral density (BMD).

Conclusion

Annual ZOL administration significantly lowers the risk of RVFs and NVFs, improving the clinical outcome of initial PKP in patients with OVCFs over a 3-year follow-up period.

Trial registration

ChiCTR2000029307

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Funding

The study was supported by Kunshan Social Development Science and Technology Project (CN) (KS18068), Beijing Bethune Charitable Foundation (CN) (B19338ES), and Suzhou Key Clinical Diagnosis and Treatment Technology Project (CN) (LCZX202024).

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Correspondence to H.-q. Shan.

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Lu, K., Yin, Y., Li, C. et al. Efficacy of annual zoledronic acid in initial percutaneous kyphoplasty patients with osteoporotic vertebral compression fractures: a 3-year follow-up study. Osteoporos Int (2021). https://doi.org/10.1007/s00198-020-05816-z

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Keywords

  • Clinical trials
  • New fracture
  • Osteoporotic vertebral compression fracture
  • Percutaneous kyphoplasty
  • Recompression
  • Zoledronic acid