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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Denosumab

Patients treated with Denosumab

Group Type ACTIVE_COMPARATOR

Denosumab

Intervention Type DRUG

Denosumab treatment one year after surgery

Placebo

Patients treated with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Serum one year after surgery

Interventions

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Denosumab

Denosumab treatment one year after surgery

Intervention Type DRUG

Placebo

Serum one year after surgery

Intervention Type DRUG

Other Intervention Names

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Prolia Serum

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No