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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02760979
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bone Resorption Drug: Denosumab Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Denosumab

Arm Intervention/treatment
Active Comparator: Denosumab
Patients treated with Denosumab
Drug: Denosumab
Denosumab treatment one year after surgery
Other Name: Prolia

Placebo Comparator: Placebo
Patients treated with placebo
Drug: Placebo
Serum one year after surgery
Other Name: Serum




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760979


Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Jose Carlos Gonzalez Orthopaedic Department-Hospital de la Santa Creu i Sant Pau
Publications:
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02760979    
Other Study ID Numbers: IIBSP-DEN-2012-24
2012-001285-15 ( EudraCT Number )
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
knee arthroplasty
Additional relevant MeSH terms:
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Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs