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.
Keywords: Clinical trials; New fracture; Osteoporotic vertebral compression fracture; Percutaneous kyphoplasty; Recompression; Zoledronic acid.