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Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

NCT03158246 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2017-05-23

No results posted yet for this study

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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

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

Sponsors & Collaborators

  • Cttq

    lead INDUSTRY

Principal Investigators

  • Xia Weibo · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
46 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-12-31
Completion
2020-03-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03158246 on ClinicalTrials.gov