NCT03158246

Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 466 (estimated)
• Sponsor: Cttq · Industry
• Sex: Female
• Age: 46 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Generic Zoledronic Acid	Generic Zoledronic Acid (Yigu®) 5mg/100ml injection
DRUG	Original Zoledronic Acid	Original Zoledronic Acid (Aclasta®) 5mg/100ml injection
DIETARY_SUPPLEMENT	calcium	600mg/d calcium for oral daily
DIETARY_SUPPLEMENT	vitamin D	925IU/d vitamin D for oral daily

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-12-31
• Completion: 2020-03-02
• First posted: 2017-05-18
• Last updated: 2017-05-23