Status:
UNKNOWN
Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid
Lead Sponsor:
Peking University Third Hospital
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
60-70 years
Phase:
PHASE4
Brief 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....
Eligibility Criteria
Inclusion
- Chinese postmenopausal women
- Aged between 60 and 70.
- Bone mineral density (BMD) values of less than 1 standard deviations (SD) below the normal adult mean.
- Willing to participate in this study.
Exclusion
- Hypersensitivity to zoledronic acid or other bisphosphonate or zoledronic acid formulation (excipients).
- Secondary osteoporosis.
- Receiving the following drugs that affect bone metabolism prior to randomization:
- (1) intravenous biphosphonates or denosumab. (2) oral biphosphonates, parathyroid hormone or its analogues, strontium, or fluoride within 12 months.
- (3) glucocorticoid, steroids, immunosuppressive agents, calcitonin, calcitriol or its analogues, thiazides diuretics, long-acting estrogen/progesterone, or statins within 3 months.
- 4\. Combine other diseases affect bone metabolism: osteogenesis imperfecta, hyperthyroidism, malignant tumors, Paget's disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, liver failure, or renal failure.
- 5\. Hyperthyroidism or hypothyroidism during screening.
- 6\. Treatment with any investigational drug within the past 3 months.
- 7\. Creatinine clearance \< 35 mL/min.
- 8\. 25(OH)D level\< 20 ng/mL.
- 9\. Serum calcium level \< 2.0 mmol/L (8 mg/dL), or \>2.8 mmol/L (11.0 mg/dL).
- 10\. Fever, severe infections, severe injuries, or major surgical operation within 30 days.
- 11\. ECG corrected QT interval (QTc) \> 480 ms.
- 12\. Pending invasive dental procedure or in progress.
- 13\. History of smoking within 6 months.
- 14\. Diabetes with fasting blood glucose ≥ 7.0 mmol/L, or glycated hemoglobin (HbA1c) \>6.3%.
- 15\. History of drug or alcohol abuse.
- 16\. History of stroke, cerebral ischemic stroke, or cerebral hemorrhage.
- 17\. Any physiological or medical condition which, in the opinion of the investigator, would preclude the participant from this trail.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04719650
Start Date
October 1 2021
End Date
November 1 2024
Last Update
June 23 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.