Five-Year Outcomes of Continuous Treatment with Zoledronic Acid Versus Denosumab in Older Men with High Fracture Risk: Risk Factor Analysis of Bone Density Improvement and Incidence of New Fracture

J Clin Pharmacol. 2024 Apr;64(4):469-477. doi: 10.1002/jcph.2378. Epub 2023 Nov 16.

Abstract

Denosumab and zoledronic acid are both effective and easily administrable injectable anti-osteoporotic medications for postmenopausal women. This study investigated the treatment efficacy of these agents in older male patients with low a bone mass and history of fragility fracture. A cohort of 175 male patients receiving continuous zoledronic acid treatment and a cohort of 366 male patients receiving continuous denosumab treatment at our medical center between 2015 and 2020 were included, and we analyzed the efficacy of treatment by the improvement in bone mineral density (BMD) and the new-onset low-energy fracture rate after 5 years of continuous medication. BMD significantly improved after 5 years of medication, and >90% of patients were satisfied with their treatment medication. BMD improved more with denosumab than with zoledronic acid, especially in patients with T-scores higher than -2.5. Smoking, alcohol abuse, diabetes, and inflammatory polyarthritis were associated with poor improvements in BMD. The incidence rate of new fragile fracture was 4.4% and old age was significantly associated with the incidence rate of new fracture. In summary, our study revealed that denosumab and zoledronic acid both significantly increased BMD among older male patients with high fragility fracture rates over a 5-year follow-up period. Early medical treatment and lifestyle adjustment were crucial for improving quality of life.

Keywords: FRAX; denosumab; new‐onset low‐energy fracture; older male with low bone mass; zoledronic acid.

MeSH terms

  • Aged
  • Bone Density
  • Bone Density Conservation Agents* / therapeutic use
  • Denosumab / adverse effects
  • Female
  • Humans
  • Incidence
  • Male
  • Osteoporosis, Postmenopausal* / drug therapy
  • Osteoporotic Fractures*
  • Quality of Life
  • Zoledronic Acid / therapeutic use

Substances

  • Zoledronic Acid
  • Denosumab
  • Bone Density Conservation Agents