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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Dates:
Date Received: April 28, 2016
Date Started: January 2013
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017