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

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

Status and phase: Completed; Phase 4

Conditions: Bone Resorption

Treatments: Drug: Denosumab; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02760979

2012-001285-15 (EudraCT Number)

IIBSP-DEN-2012-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Denosumab

Active Comparator group

Description:

Patients treated with Denosumab

Treatment:

Drug: Denosumab

Placebo

Placebo Comparator group

Description:

Patients treated with placebo

Treatment:

Drug: Placebo