Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid
Postmenopausal Osteoporosis
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring zoledronic acid, pharmacokinetic, pharmacodynamic, Chinese osteoporosis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
zoledronic acid 1mg
zoledronic acid 2.5mg
zoledronic acid 5mg
placebo
Add 20 mL of Zoledronic acid injection (100mL : 5mg) with 80 mL of normal saline to 100 mL. Infusion 20 minutes with constant speed. Administration only once.
Add 50 mL of Zoledronic acid injection (100mL : 5mg) with 50 mL of normal saline to 100 mL. Infusion 20 minutes with constant speed. Administration only once.
Infusion 100 mL of Zoledronic acid injection (100mL : 5mg) with constant speed in 20 minutes. Administration only once.
Infusion 100 mL of normal saline with constant speed in 20 minutes. Administration only once.