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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab 60 MG/ML Injectable Solution [Prolia] | Drug | 1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after TKA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Microarchitecture | Bone Microarchitecture on microCT | 8 weeks |
| Bone turnover markers | βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| intermuscular and intramuscular adipose | intermuscular and intramuscular adipose on biopsy slice | 8 weeks |
| Mankin Histological-Histochemical Grading of Cartilage | Mankin Histological-Histochemical Grading of Cartilage |
| Measure | Description | Time Frame |
|---|---|---|
| Certain protein expression in bone, muscle, synovium and cartilage | Certain protein expression in bone, muscle, synovium and cartilage | 8 weeks |
Inclusion Criteria:
Patients with Bilateral Knee Osteoarthritis treated with Staged Bilateral Total Knee Arthroplasty, with an Interval of 8 weeks
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuai Xiang, M.D, | Contact | +86-18661809209 | 15169093669@163.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo | Drug | 1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA |
|
| 8 weeks |
| Histopathological grading of synovium | Histopathological grading of synovium | 8 weeks |
| D012216 |
| Rheumatic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |