osteoporosis
Conditions
Interventions
Gyromagnet group:Gyromagnet therapy
Sponsors
Shenzhen Heng'an Hongyuan Magnetic Technology Co., LTD.
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 45-80 years, no gender limit; 2. Patients with bone mineral density T-value (dual-energy X-ray absorption method) <= 2.5 standard deviation of peak bone mass in lumbar spine (L2, L3, L4, L2-L4) or hip (femoral neck, femoral greater trochanter, Wards triangle); 3. Patients diagnosed with osteoporosis; 4. Patients or their guardians volunteered to participate in the trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with known or suspected severe magnetic field allergy; 2. Patients with known thalassemia; 3. Patients with abnormal coagulation function and bleeding tendency (platelet 1.5); 4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times of the normal upper limit; 5. Serum creatinine (Cr) > 2mg/dl (177umol/L); 6. Patients with a history of malignant tumors, hyperuricemia, and hypercalcemia; 7. Patients with implantable pacemakers, insulin pumps and other metals in their bodies; 8. Patients with bone mineral density test site with bone plate, bone nail and other implants; 9. Patients with hyperthyroidism, primary hyperparathyroidism, multiple myeloma, secondary hypoadrenocortical disease and other diseases seriously affecting osteoporosis; 10. Patients who used thyroxine, calcitonin, diphosphonates (except zoledronic acid), warfarin, estrogen, progesterone, androgen, antiepileptic drugs (phenytoin, preecenone, phenobarbital, carbamazepine) within 3 months before enrollment; 11. Patients who used zoledronic acid within 2 years before enrollment; 12. Long-term use or ongoing use of glucocorticoids; 13. Patients with critical organ failure or other serious diseases, or myocardial infarction occurred within 12 months before enrollment; Severely infected patients; 14. Men with fertility plans; 15. Pregnant or lactating patients; 16. Participated in any other clinical trials of drugs or medical devices within 3 months before enrollment; 17. Those who were deemed unsuitable to participate in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density;Bone pain conditions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fracture incidence;Amino-terminal propeptide of type ? collagen;Special sequence of carboxyl terminal peptide ß of type ? collagen;Blood calcium;Blood phosphorus;Incidence of adverse events;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactWang Jianwei
Guangzhou First People's Hospital
Outcome results
None listed