Primary osteoporosis ?Osteoporotic fracture
Conditions
Interventions
experimental group:Zoledronic acid injection
Sponsors
Chizhou People's Hospital
Eligibility
Sex/Gender
Female
Age
46 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 46-80 years with natural menopause for more than 1 year; 2. Patients who meet the diagnostic criteria of osteoporosis and are diagnosed as osteoporosis; Diagnostic criteria for osteoporosis (one of the following three criteria is met); (1) Brittle fracture of hip or vertebral body; (2) The t-value of BMD measured by DXA was 35ml / min; 6. The patients agreed to join the clinical trial, voluntarily signed the informed consent form, and agreed to participate in all visits, examinations and treatments according to the requirements of the trial protocol, and cooperate with the researchers of this subject.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to bisphosphonates or any of the excipients in drug ingredients; 2. Patients with various endocrine and metabolic diseases that cause secondary osteoporosis (such as hyperparathyroidism, diabetes and other diseases that seriously affect bone or calcium metabolism); 3. Patients with severe liver and renal insufficiency and long-term treatment with glucocorticoid or immunosuppressive agents; 4. The patients took drugs that affect bone metabolism within 3 months; 5. Hypocalcemia, renal insufficiency and hypercalcemia; 6. Patients with malignant tumor; 7. Patients with severe infection; 8. Patients with severe liver disease and liver cirrhosis, severe cardiac insufficiency, severe atrial fibrillation, and arterial calcification; 9. Patients who have participated in clinical trials of other research drugs in the past four weeks; 10. Patients with poor compliance and unable to complete the trial according to the study protocol; 11. For any reason, the subject was considered unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lumbar bone mineral density;BMD of total hip and femoral neck; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone formation index P1NP;Bone resorption index S-CTX;Fracture rate;Pain relief;Occurrence and remission of adverse reactions; | — |
Countries
China
Contacts
Public ContactGuijie Xie
Chizhou People's Hospital
Outcome results
None listed