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Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Denosumab 60 MG/ML Injectable Solution [Prolia]
Placebo
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Denosumab

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Bone Microarchitecture
    Bone Microarchitecture on microCT
    Bone turnover markers
    βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP

    Secondary Outcome Measures

    intermuscular and intramuscular adipose
    intermuscular and intramuscular adipose on biopsy slice
    Mankin Histological-Histochemical Grading of Cartilage
    Mankin Histological-Histochemical Grading of Cartilage
    Histopathological grading of synovium
    Histopathological grading of synovium

    Full Information

    First Posted
    September 25, 2022
    Last Updated
    September 28, 2022
    Sponsor
    The Affiliated Hospital of Qingdao University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05559268
    Brief Title
    Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Affiliated Hospital of Qingdao University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Denosumab
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Denosumab 60 MG/ML Injectable Solution [Prolia]
    Intervention Description
    1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after TKA
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    1 ml (60 mg) subcutaneous injection Saline give in the posterior part of the upper arm after TKA
    Primary Outcome Measure Information:
    Title
    Bone Microarchitecture
    Description
    Bone Microarchitecture on microCT
    Time Frame
    8 weeks
    Title
    Bone turnover markers
    Description
    βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    intermuscular and intramuscular adipose
    Description
    intermuscular and intramuscular adipose on biopsy slice
    Time Frame
    8 weeks
    Title
    Mankin Histological-Histochemical Grading of Cartilage
    Description
    Mankin Histological-Histochemical Grading of Cartilage
    Time Frame
    8 weeks
    Title
    Histopathological grading of synovium
    Description
    Histopathological grading of synovium
    Time Frame
    8 weeks
    Other Pre-specified Outcome Measures:
    Title
    Certain protein expression in bone, muscle, synovium and cartilage
    Description
    Certain protein expression in bone, muscle, synovium and cartilage
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shuai Xiang, M.D,
    Phone
    +86-18661809209
    Email
    15169093669@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty

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