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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02760979
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date  ICMJE April 28, 2016
First Posted Date  ICMJE May 4, 2016
Last Update Posted Date August 11, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Change in Bone Mass index [ Time Frame: Change in densitometry before surgery (0) and at three (3) months after surgery ]
    Bone Mass index in gr/cm3
  • Change in Bone Mass index [ Time Frame: Change in densitometry before surgery (0) and at six (6) months after surgery ]
    Bone Mass index in gr/cm3
  • Change in Bone Mass index [ Time Frame: Change in densitometry before surgery (0) and at twelve (12) months after surgery ]
    Bone Mass index in gr/cm3
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Quality of Life (WOMAC) [ Time Frame: WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery ]
  • Quality of life (SF-36) [ Time Frame: SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery ]
  • Kidney function [ Time Frame: Before surgery and at three, six and twelve months after surgery ]
    Creatinine clearance
  • Liver function [ Time Frame: Before surgery and at three, six and twelve months after surgery ]
    ALT, AST
  • Bone turnover markers [ Time Frame: At three, six and twelve months after surgery ]
    Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
Official Title  ICMJE The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Bone Resorption
Intervention  ICMJE
  • Drug: Denosumab
    Denosumab treatment one year after surgery
    Other Name: Prolia
  • Drug: Placebo
    Serum one year after surgery
    Other Name: Serum
Study Arms  ICMJE
  • Active Comparator: Denosumab
    Patients treated with Denosumab
    Intervention: Drug: Denosumab
  • Placebo Comparator: Placebo
    Patients treated with placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2016)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02760979
Other Study ID Numbers  ICMJE IIBSP-DEN-2012-24
2012-001285-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose Carlos Gonzalez Orthopaedic Department-Hospital de la Santa Creu i Sant Pau
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP