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Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid

NCT04719650 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-06-23

No results posted yet for this study

Summary

The recommended dosing regimen of zoledronic acid in Chinese osteoporosis patients is completely in accordance with the one of 5 mg per year abroad that based on the dosing regimen in Paget's disease. This dosing regimen lacks the actual supportive clinical data of Chinese patients. In addition, the overall incidence of acute phase response, the main adverse event after the first infusion, in Chinese patients is higher than that in Caucasian patients population. Moreover, the results of the similar drug clinical study in the Japanese patients shown that the purpose of effective treatment for osteoporosis could be achieved with half of the dosage in Caucasian population. Thus, it could be inferred from these that the dosing regimen of zoledronic acid might be inappropriate in Chinese osteoporosis patients. Therefore, the main purpose of this clinical trail is to compare the zoledronic acid pharmacokinetic and pharmacodynamic characteristic of different doses in Chinese postmenopausal subjects with low bone mass or osteoporosis and explore the best dosing regimen in Chinese patients.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Zoledronic Acid Injection

Infusion 1mg zoledronic acid once.

DRUG

Zoledronic Acid Injection

Infusion 2.5mg zoledronic acid once.

DRUG

Zoledronic Acid Injection

Infusion 5mg zoledronic acid once.

DRUG

Placebo

Infusion normal saline once.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Chunli Song, M.D.; Ph. D. · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2024-10-31
Completion
2024-11-30

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Drugs

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 NCT04719650 on ClinicalTrials.gov