Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05559268
• Other study ID #: Denosumab AHQD
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: Shuai Xiang, M.D,
• Phone: +86-18661809209
• Email: 15169093669[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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
• Placebo
1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Certain protein expression in bone, muscle, synovium and cartilage	Certain protein expression in bone, muscle, synovium and cartilage	8 weeks
Primary	Bone Microarchitecture	Bone Microarchitecture on microCT	8 weeks
Primary	Bone turnover markers	ßCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP	8 weeks
Secondary	intermuscular and intramuscular adipose	intermuscular and intramuscular adipose on biopsy slice	8 weeks
Secondary	Mankin Histological-Histochemical Grading of Cartilage	Mankin Histological-Histochemical Grading of Cartilage	8 weeks
Secondary	Histopathological grading of synovium	Histopathological grading of synovium	8 weeks