Randomized controlled trial of zoledronic acid for treatment of osteoporosis in women

J Int Med Res. 2013 Jun;41(3):697-704. doi: 10.1177/0300060513480917. Epub 2013 May 13.


Objective: To assess the effect of zoledronic acid (ZOL) on bone mineral density (BMD) and fracture risk at the L1-L4 vertebrae, femoral neck, hip and trochanter in Chinese women with osteoporosis.

Methods: A randomized controlled trial was conducted in female patients with osteoporosis, randomized to receive one 5-mg ZOL intravenous infusion per year or placebo equivalent. Facture risk and BMD were measured over a 2-year follow-up period.

Results: A statistically significant reduction in the risk of fracture was observed at the trochanter in the ZOL group (n = 242) compared with the placebo group (n = 241); (odds ratio 0.54 [95% confidence interval 0.29, 0.98]): BMD was 0.24, 0.28, 0.31 and 0.22 greater at the L1-L4 vertebrae, total hip, femoral neck and trochanter, respectively, in the ZOL group. The incidence of adverse events was comparable between treatment groups.

Conclusions: This study indicated that ZOL could increase BMD and reduce fracture risk in women with osteoporosis over a 2-year follow-up period, and was not associated with any serious drug-related adverse effects.

Keywords: Zoledronic acid; bone mineral density; fracture; osteoporosis; randomized controlled trial.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Asian People
  • Bone Density / drug effects*
  • Bone Density Conservation Agents / therapeutic use*
  • Diphosphonates / therapeutic use*
  • Drug Administration Schedule
  • Female
  • Femur / drug effects
  • Femur / pathology
  • Femur Neck / drug effects
  • Femur Neck / pathology
  • Follow-Up Studies
  • Fractures, Bone / ethnology
  • Fractures, Bone / prevention & control*
  • Hip / pathology
  • Humans
  • Imidazoles / therapeutic use*
  • Infusions, Intravenous
  • Middle Aged
  • Osteoporosis, Postmenopausal / drug therapy*
  • Osteoporosis, Postmenopausal / ethnology
  • Osteoporosis, Postmenopausal / pathology
  • Spine / drug effects
  • Spine / pathology
  • Zoledronic Acid


  • Bone Density Conservation Agents
  • Diphosphonates
  • Imidazoles
  • Zoledronic Acid