Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT04719650
Eligibility Criteria:
Inclusion Criteria:
1. Chinese postmenopausal women
2. Aged between 60 and 70.
3. Bone mineral density (BMD) values of less than 1 standard deviations (SD) below the normal adult mean.
4. Willing to participate in this study.
Exclusion Criteria:
1. Hypersensitivity to zoledronic acid or other bisphosphonate or zoledronic acid formulation (excipients).
2. Secondary osteoporosis.
3. 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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
70 Years
Study:
NCT04719650
Study Brief:
Protocol Section:
NCT04719650