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Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05559268
Collaborator
(none)
60
Enrollment
2
Arms
15
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Denosumab 60 MG/ML Injectable Solution [Prolia]
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Denosumab

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 Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Bone Microarchitecture [8 weeks]

    Bone Microarchitecture on microCT

  2. Bone turnover markers [8 weeks]

    βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP

Secondary Outcome Measures

  1. intermuscular and intramuscular adipose [8 weeks]

    intermuscular and intramuscular adipose on biopsy slice

  2. Mankin Histological-Histochemical Grading of Cartilage [8 weeks]

    Mankin Histological-Histochemical Grading of Cartilage

  3. Histopathological grading of synovium [8 weeks]

    Histopathological grading of synovium

Other Outcome Measures

  1. Certain protein expression in bone, muscle, synovium and cartilage [8 weeks]

    Certain protein expression in bone, muscle, synovium and cartilage

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Affiliated Hospital of Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiang Shuai, MD, Dr., The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier:
NCT05559268
Other Study ID Numbers:
  • Denosumab AHQD
First Posted:
Sep 29, 2022
Last Update Posted:
Sep 29, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis, Knee
Denosumab

Study Results

No Results Posted as of Sep 29, 2022