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

Study Overview
=================
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.

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

Conditions
-----------------
Bone Resorption

Intervention / Treatment
-----------------
* Drug: Denosumab
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Denosumab<br>Patients treated with Denosumab | Drug: Denosumab<br>* Denosumab treatment one year after surgery<br>* Other names: Prolia;|
| Placebo Comparator: Placebo<br>Patients treated with placebo | Drug: Placebo<br>* Serum one year after surgery<br>* Other names: Serum;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bone Mass index | Bone Mass index in gr/cm3 | Change in densitometry before surgery (0) and at three (3) months after surgery | 
| Change in Bone Mass index | Bone Mass index in gr/cm3 | Change in densitometry before surgery (0) and at six (6) months after surgery | 
| Change in Bone Mass index | Bone Mass index in gr/cm3 | Change in densitometry before surgery (0) and at twelve (12) months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (WOMAC) |  | WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery | 
| Quality of life (SF-36) |  | SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery | 
| Kidney function | Creatinine clearance | Before surgery and at three, six and twelve months after surgery | 
| Liver function | ALT, AST | Before surgery and at three, six and twelve months after surgery | 
| Bone turnover markers | Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP) | At three, six and twelve months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee arthroplasty