Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty
- Conditions
- Osteoarthritis, Knee
- Interventions
- Registration Number
- NCT05559268
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- Brief Summary
This study evaluates single dose of Denosumab in decreasing systemic and periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within 2 months after surgery. This study also evaluates the anti-RANKL effect of single dose of Denosumab in serum, skeletal muscle, synovium, fat, and cartilage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Patients with Bilateral Knee Osteoarthritis treated with Staged Bilateral Total Knee Arthroplasty, with an Interval of 8 weeks
Patients allergies to Denosumab Patients with previous Osteoporosis treatment Patients with renal failure Patients with previous Bisphosphonate treatment for more than 5 years Patients failed to finish contralateral Total Knee Arthroplasty at 8 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Denosumab Denosumab 60 MG/ML Injectable Solution [Prolia] - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Bone Microarchitecture 8 weeks Bone Microarchitecture on microCT
Bone turnover markers 8 weeks βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP
- Secondary Outcome Measures
Name Time Method intermuscular and intramuscular adipose 8 weeks intermuscular and intramuscular adipose on biopsy slice
Mankin Histological-Histochemical Grading of Cartilage 8 weeks Mankin Histological-Histochemical Grading of Cartilage
Histopathological grading of synovium 8 weeks Histopathological grading of synovium