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Completed

NCT Number: NCT02760979

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

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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Key information

Conditions

Bone Resorption Bone Diseases Musculoskeletal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denosumab

Drug

Denosumab treatment one year after surgery

Other names: Prolia

Placebo

Drug

Serum one year after surgery

Other names: Serum

Primary outcomes

  1. Change in Bone Mass index

    Time frame: Change in densitometry before surgery (0) and at three (3) months after surgery

    Bone Mass index in gr/cm3

  2. Change in Bone Mass index

    Time frame: Change in densitometry before surgery (0) and at six (6) months after surgery

    Bone Mass index in gr/cm3

  3. Change in Bone Mass index

    Time frame: Change in densitometry before surgery (0) and at twelve (12) months after surgery

    Bone Mass index in gr/cm3

Secondary outcomes

  1. Quality of Life (WOMAC)

    Time frame: WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery

  2. Quality of life (SF-36)

    Time frame: SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery

  3. Kidney function

    Time frame: Before surgery and at three, six and twelve months after surgery

    Creatinine clearance

  4. Liver function

    Time frame: Before surgery and at three, six and twelve months after surgery

    ALT, AST

  5. Bone turnover markers

    Time frame: At three, six and twelve months after surgery

    Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 4, 2016
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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