Patients with osteoporosis
Conditions
Interventions
Observation Group 1(Patients with postmenopausal osteoporosis who underwent total knee arthroplasty received a treatment regimen of denosumab injection (Luxapin?) after surgery):None
Observation Group 2(Patients with postmenopausal osteoporosis who underwent total knee arthroplasty received a treatment regimen of Denosumab Injection (original research) after surgery):None
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 50 years old; 2. Postmenopausal women, defined as those who have experienced menopause after the age of 40 and have been postmenopausal for more than 2 years (calculated from the date of signing the informed consent form), i.e., experiencing spontaneous amenorrhea for more than 2 years or having undergone bilateral oophorectomy for more than 2 years; 3. Lumbar or hip BMD: -4.0 < T <= -2.5; 4. Proposed initial total knee arthroplasty (TKA) for primary osteoarthritis; 5. Sign the informed consent form and agree to comply with the research requirements.
Exclusion criteria
Exclusion criteria: 1. Suffering from diseases that can affect bone metabolism: various metabolic bone diseases (such as osteomalacia or osteogenesis imperfecta; Paget's disease, Cushing's syndrome, hyperprolactinemia, hypopituitarism, acromegaly, multiple myeloma), severe digestive tract diseases (including long-term chronic diarrhea), severe hepatic insufficiency [ALT or AST >= 3ULN, or alkaline phosphatase or total bilirubin >= 2.5 ULN (if bilirubin classification testing is performed and direct bilirubin = 1.5 ULN is allowed to be included)], severe renal insufficiency (creatinine clearance rate 8.0%), and drug-induced secondary osteoporosis; 2. Patients undergoing total knee arthroplasty who require the implantation of non-cemented prostheses or the addition of an extension rod implant; 3. Suffering from active malignant tumors, except for completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or breast ductal carcinoma; 4. There is evidence of past or current osteomyelitis or osteonecrosis of the jaw; 5. Those who have received treatment with bisphosphonates, fluoride, or strontium agents within 6 months; 6. Those who have received teriparatide and denosumab treatment within 6 months; 7. Within 3 months, have received and plan to continue using anabolic steroids or testosterone, glucocorticoids, sex hormone replacement therapy, selective estrogen receptor modulators (SERMs), such as raloxifene; calcitonin, calcitriol, vitamin D derivatives (cumulative use =2.0 mmol/L (8.0 mg/dL) or >=2.9 mmol/L (11.5 mg/dL)]; subjects must not take calcium supplements at least 8 hours before blood is drawn for serum calcium screening determination; 10. Known hypersensitivity or delayed-type hypersensitivity to certain components of the study drug or similar drugs; 11. Participating in an interventional clinical trial of other drugs or devices that affect osteoporosis treatment; 12. Other situations where the researchers assessed as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum displacement of knee joint prosthesis(MTPM);Compare the differences in HSS score, VAS score, and WOMAC score of the knee joint at 3, 6, and 12 months between the treatment with Denosumab (Luxin?) and Denosumab (original research); | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in maximum translational position of the knee prosthesis (MTPM);Comparing the difference in the incidence of new fragility fractures within 12 months between treatment with Denosumab (Luxapton?) and Denosumab (original research);Comparison of the percentage difference in changes from baseline in BMD of thoracic and lumbar vertebrae, and total hip at 12 months of treatment between Denosumab (Luxapin?) and Denosumab (original research); | — |
Countries
China
Contacts
Public ContactHuang Wei
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed