osteoporotic fractures
Conditions
Interventions
one:Denosumab 3 years
two:Denosumab 2 years followed by zoledronic acid 1 year
three:zoledronic acid 3 years
Sponsors
Shanghai Jiaotong University School of Medicine Affiliated Ruijin Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent form 2. Promise to comply with research procedures and cooperate in implementing full process research 3. Women aged between 45 and 100 years old, and fracture patients with lumbar or total hip bone density T-scores below -2.5; Or low-energy Osteoporosis fractures caused by quantitative violence, such as hip fractures, distal radius fractures, spinal fractures, proximal humeral fractures, and ankle fractures, surgery is needed to treat the patient 4. Oral bisphosphonates, used for more than 48 weeks (1 year) with 2-year intervals 5. Oral bisphosphonates, used for more than 8 weeks but less than 48 weeks, with an interval of 1 year 6. Oral bisphosphonates, used for more than 2 weeks but less than 8 weeks, with an interval of six months 7. Intravenous administration of zoledronic acid with a 2-year interval 8. Terapatide is used for less than 1 week with an interval of 3 months 9. Use of calcitonin for more than 4 weeks but less than 12 weeks, with an interval of 3 months 10. Use of calcitonin for more than 12 weeks with a 6-month interval 11. Oral or intravenous corticosteroids, with a 1-year interval 12. Can persist and cooperate with research interventions
Exclusion criteria
Exclusion criteria: 1. Patients with diseases that affect bone metabolism (Paget's disease, active hyperthyroidism, primary hyperparathyroidism or hypoparathyroidism, and bone tumors). 2. The creatinine clearance rate is less than 30ml ml/min. 3. For patients with contraindications to desucumab and zoledronic acid. 4. The use of oral bisphosphonates, intravenous zoledronic acid, terlipide, calcitonin, or glucocorticoids does not meet the inclusion criteria for drugs intermittent patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing time within 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in bone metabolism indicators compared to baseline at at 12, 24 and 36 months;Percentage change in BMD compared to baseline at 12, 24 and 36 months;Percentage change in grip strength compared to baseline at 12, 24 and 36 months;The incidence of new fractures (non vertebral fractures and clinical vertebral fractures) within 36 months; | — |
Countries
China
Contacts
Public ContactChangjun Guo
Shanghai Jiaotong University School of Medicine Affiliated Ruijin Hospital
Outcome results
None listed