Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid
Status:
Not yet recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
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.