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