Knee Osteoarthritis (KOA) combined with Osteoporosis (OP)
Conditions
Interventions
The denosumab group (undergoing total knee arthroplasty and using denosumab + vitamin D + calcium):After the patients TKA surgery, they began receiving anti-osteoporosis treatment. The dose of denosum
The teriparatide group (undergoing total knee arthroplasty and using teriparatide + vitamin D + calcium):After the patients TKA surgery, they started receiving anti-osteoporosis treatment. The dose o
The control group (undergoing total knee arthroplasty and using vitamin D + calcium):Calcium supplement: 600mg, oral administration, once a day (Caltrate, Wyeth). Alfacalcidol: 0.5µg, oral administra
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged 60–80 years and postmenopausal women; 2. Diagnosed with knee osteoarthritis (KOA) unresponsive to conservative treatment; 3. Assessed by the investigator as requiring first-time unilateral total knee arthroplasty; 4. All participants underwent preoperative quantitative CT (qCT) bone mineral density assessment (lumbar spine and hip) and were diagnosed with osteoporosis (T-value <= -3.0); 5. Subjects fully understand the potential benefits and risks of this trial, voluntarily agree to participate, and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) > 35 kg/m^²; 2. Patients with failure of vital organ functions, including cardiac or pulmonary dysfunction; 3. Abnormal liver or kidney function (ALT, AST > 1.5 times the upper limit of normal, blood BUN > 8.3 mmol/L, blood Scr > 115 µmol/L), or abnormal serum calcium levels precluding the use of denosumab; 4. Coexisting disturbance of consciousness or psychiatric illness; 5. History of prior open knee surgery; 6. Neuromuscular dysfunction impairing lower limb function; 7. Severe coagulopathy; 8. Coexisting severe medical or surgical conditions, or poor physical condition, rendering the patient unfit for surgery; 9. Ineligible for conventional total knee arthroplasty (TKA), including cases with ligament instability requiring concomitant ligament reconstruction, or those requiring constrained prostheses or prostheses with stems; 10. Active infection foci (systemic or localized); 11. Coexisting metabolic bone disease, radiation-induced bone disease, tumors, or other conditions that may compromise periprosthetic bone mass around the knee; 12. Participation in any other clinical trial within the past 3 months; 13. Any other reason, as determined by the investigator, that renders the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density around the prosthesis;Bone metabolism indicators (tPINP, ß-CTX, N-MID);Bone microstructure and bone permeability;Prosthesis stability;Parathyroid hormone;N-terminal mid-molecular fragment of osteocalcin;25-hydroxyvitamin D;Total Type I Collagen Amino-Terminal Propeptide;Serum bone-specific alkaline phosphatase mass;ß-collagen degradation product; | — |
Secondary
| Measure | Time frame |
|---|---|
| Joint function scores;The quality of life of the patient;Prosthesis survival rate; | — |
Countries
China
Contacts
Public ContactZeng Yi
West China Hospital, Sichuan University
Outcome results
None listed