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The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty

Primary Purpose

Bone Resorption

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Denosumab
Placebo
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Resorption focused on measuring knee arthroplasty

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Denosumab

    Placebo

    Arm Description

    Patients treated with Denosumab

    Patients treated with placebo

    Outcomes

    Primary Outcome Measures

    Change in Bone Mass index
    Bone Mass index in gr/cm3
    Change in Bone Mass index
    Bone Mass index in gr/cm3
    Change in Bone Mass index
    Bone Mass index in gr/cm3

    Secondary Outcome Measures

    Quality of Life (WOMAC)
    Quality of life (SF-36)
    Kidney function
    Creatinine clearance
    Liver function
    ALT, AST
    Bone turnover markers
    Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)

    Full Information

    First Posted
    April 28, 2016
    Last Updated
    August 10, 2017
    Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02760979
    Brief Title
    The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
    Official Title
    The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.
    Detailed Description
    Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery. 2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption
    Keywords
    knee arthroplasty

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Denosumab
    Arm Type
    Active Comparator
    Arm Description
    Patients treated with Denosumab
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients treated with placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Denosumab
    Other Intervention Name(s)
    Prolia
    Intervention Description
    Denosumab treatment one year after surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Serum
    Intervention Description
    Serum one year after surgery
    Primary Outcome Measure Information:
    Title
    Change in Bone Mass index
    Description
    Bone Mass index in gr/cm3
    Time Frame
    Change in densitometry before surgery (0) and at three (3) months after surgery
    Title
    Change in Bone Mass index
    Description
    Bone Mass index in gr/cm3
    Time Frame
    Change in densitometry before surgery (0) and at six (6) months after surgery
    Title
    Change in Bone Mass index
    Description
    Bone Mass index in gr/cm3
    Time Frame
    Change in densitometry before surgery (0) and at twelve (12) months after surgery
    Secondary Outcome Measure Information:
    Title
    Quality of Life (WOMAC)
    Time Frame
    WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery
    Title
    Quality of life (SF-36)
    Time Frame
    SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery
    Title
    Kidney function
    Description
    Creatinine clearance
    Time Frame
    Before surgery and at three, six and twelve months after surgery
    Title
    Liver function
    Description
    ALT, AST
    Time Frame
    Before surgery and at three, six and twelve months after surgery
    Title
    Bone turnover markers
    Description
    Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)
    Time Frame
    At three, six and twelve months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jose Carlos Gonzalez
    Organizational Affiliation
    Orthopaedic Department-Hospital de la Santa Creu i Sant Pau
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10884214
    Citation
    Ishii Y, Yagisawa K, Ikezawa Y. Changes in bone mineral density of the proximal femur after total knee arthroplasty. J Arthroplasty. 2000 Jun;15(4):519-22. doi: 10.1054/arth.2000.4639.
    Results Reference
    background
    PubMed Identifier
    10037335
    Citation
    Sugita T, Umehara J, Sato K, Inoue H. Influence of tibial bone quality on loosening of the tibial component in total knee arthroplasty for rheumatoid arthritis: long-term results. Orthopedics. 1999 Feb;22(2):213-5. doi: 10.3928/0147-7447-19990201-10.
    Results Reference
    background
    PubMed Identifier
    14630840
    Citation
    Wang CJ, Wang JW, Weng LH, Hsu CC, Huang CC, Chen HS. The effect of alendronate on bone mineral density in the distal part of the femur and proximal part of the tibia after total knee arthroplasty. J Bone Joint Surg Am. 2003 Nov;85(11):2121-6. doi: 10.2106/00004623-200311000-00009.
    Results Reference
    background

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    The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty

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