NCT05559268

Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Denosumab 60 MG/ML Injectable Solution [Prolia]	1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after TKA
DRUG	Placebo	1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-09-29
• Last updated: 2022-09-29