NCT04719650

Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid

The Pharmacokinetics and Pharmacodynamics Study of Intravenous Zoledronic Acid in Chinese Subjects With Low Bone Mass or Osteoporosis: a Randomized Placebo-controlled Trail

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 60 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-10-01
• Completion: 2024-11-01
• First posted: 2021-01-22
• Last updated: 2021-06-23