Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

Summary

This study compares the efficacy and safety of generic zoledronic acid (Yigu®) and original zoledronic acid (Aclasta®) in the treatment of postmenopausal osteoporotic women in China. Four hundred and sixty-six subjects will be randomised (1:1ratio) to either Yigu® 5mg IV or Aclasta® 5mg IV treatment arms.

Timeline

Start

2017-06-01

Primary completion

2019-12-31

Completion

2020-03-02

Publications

• Du Y, Yu W, Gou H, Lei Y, Zhang T, Tang W, Chen M, Li H, Cheng Q. Change in body temperature, not acute-phase reaction, predict anti-Osteoporosis efficacy after the first administration of Zoledronic acid: a prospective observational cohort study. BMC Musculoskelet Disord. 2024 Sep 2;25(1):694. doi: 10.1186/s12891-024-07781-8.

Drugs

Indications