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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after TKA
1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA
Bone Microarchitecture
Bone Microarchitecture on microCT
Time frame: 8 weeks
Bone turnover markers
βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP
Time frame: 8 weeks
intermuscular and intramuscular adipose
intermuscular and intramuscular adipose on biopsy slice
Time frame: 8 weeks
Mankin Histological-Histochemical Grading of Cartilage
Mankin Histological-Histochemical Grading of Cartilage
Time frame: 8 weeks
Histopathological grading of synovium
Histopathological grading of synovium
Time frame: 8 weeks
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