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Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

NCT05559268 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-09-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05559268 on ClinicalTrials.gov