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

Phase 4

Completed

• Conditions: Bone Resorption
• Interventions: Drug: Placebo; Drug: Denosumab

• Registration Number: NCT02760979
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2015-06
• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients treated with placebo
Denosumab	Denosumab	Patients treated with Denosumab

Primary Outcome Measures

Name	Time	Method
Change in Bone Mass index	Change in densitometry before surgery (0) and at twelve (12) months after surgery	Bone Mass index in gr/cm3

Secondary Outcome Measures

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