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

F

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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