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Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

Osteoporosis, Postmenopausal Clinical Trial

Official title:
Generic Zoledronic Acid Versus Original Zoledronic Acid: A Multicenter, Randomized, Open, Paralled-controlled Clinical Postmenopausal Osteoporotic Women Efficacy and Safety Research.

Clinical Trial 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.

Clinical Trial Description

A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis, and it significantly reduced the risk of vertebral fractures additionally.

In this research, the efficacy and safety of generic zoledronic acid injection in the treatment of postmenopausal osteoporosis will be evaluated, using original drug as control drug. It will provide evidence for reasonable clinical administrations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03158246
Study type Interventional
Source Cttq
Contact Li Mei
Phone +86 13671312468
Email limeilzh@sina.com
Status Not yet recruiting
Phase Phase 4
Start date June 1, 2017
Completion date March 2, 2020
View Details
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