Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

September 28, 2022 updated by: Xiang Shuai, MD, The Affiliated Hospital of Qingdao University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Microarchitecture
Time Frame: 8 weeks
Bone Microarchitecture on microCT
8 weeks
Bone turnover markers
Time Frame: 8 weeks
βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intermuscular and intramuscular adipose
Time Frame: 8 weeks
intermuscular and intramuscular adipose on biopsy slice
8 weeks
Mankin Histological-Histochemical Grading of Cartilage
Time Frame: 8 weeks
Mankin Histological-Histochemical Grading of Cartilage
8 weeks
Histopathological grading of synovium
Time Frame: 8 weeks
Histopathological grading of synovium
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Certain protein expression in bone, muscle, synovium and cartilage
Time Frame: 8 weeks
Certain protein expression in bone, muscle, synovium and cartilage
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (ACTUAL)

September 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Denosumab AHQD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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