The Affiliated Hospital of Qingdao University
Ang Swai, MD
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.
Osteoarthritis, Knee
Denosumab 60 MG/ML Injectable Solution [Prolia]
Placebo
Phase 4
| Study Type : | Interventional |
| Estimated Enrollment : | 60 participants |
| Masking : | Quadruple |
| Primary Purpose : | Treatment |
| Official Title : | Single Dose Subcutaneous Injections of Denosumab for Patients Underwent Cemented Total Knee Arthroplasty. A Randomized Controlled Study on the Effects on Bone Microarchitecture, Skeletal Muscle, Cartilage and Synovium |
| Actual Study Start Date : | October 1, 2022 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Denosumab |
Drug: Denosumab 60 MG/ML Injectable Solution [Prolia] |
|
Placebo Comparator: Placebo |
Drug: Placebo |
| Ages Eligible for Study: | 50 Years to 75 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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