Prednisolone Urinary Excretion Kinetics

Overview

The urinary elimination kinetics of glucocorticoids after intra-articular injection is very poorly documented. It is estimated that glucocorticoids may be present in the urine up to 6 weeks after intra-articular injection. However, this is not supported by any scientific literature. Despite this lack of evidence, in doping control practice, any presence of glucocorticoids in urine is accepted when the athlete provides evidence of an intra-articular injection that took place less than 6 weeks prior to the doping control. Many doping cases are open to challenge because they are based solely on measurements of prednisolone concentrations and its blood esterase product, prednisone. In order to demonstrate the use of prednisolone for doping purposes (systemic and not intra-articular use), it is therefore necessary to know the urinary elimination kinetics of prednisolone and prednisone, as well as the evolution of the concentration ratio between these 2 molecules.

Full Title of Study: “A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2023

Interventions

  • Drug: Prednisolone
    • In this routine care study, all patients will receive a joint injection of prednisolone at a dose left to the discretion of the physician. The urinary excretion kinetics of this product and its metabolites will then be followed at different times. An association with metabolic genetic profile will be done.

Arms, Groups and Cohorts

  • Knee infiltration
    • Patients requiring prednisolone knee infiltration as part of routine medical management

Clinical Trial Outcome Measures

Primary Measures

  • Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
    • Time Frame: Pre-intervention (infiltration)
    • Urinary dosing
  • Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
    • Time Frame: Hour24 after intervention
    • Urinary dosing
  • Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
    • Time Frame: Hour48 after intervention
    • Urinary dosing
  • Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
    • Time Frame: Day7 after intervention
    • Urinary dosing
  • Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
    • Time Frame: Day14 after intervention
    • Urinary dosing
  • Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
    • Time Frame: Day28 after intervention
    • Urinary dosing
  • Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
    • Time Frame: Day42 after intervention
    • Urinary dosing

Participating in This Clinical Trial

Inclusion Criteria

  • – Male or female – 18-65 years old – requiring intra-articular injection of prednisolone as part of routine care – naive to any corticosteroid administration – requiring a blood biology test as part of routine care and before the infiltration procedure – For women of childbearing age, negative urine pregnancy test at inclusion – Affiliated to a social health insurance plan – Able to understand the protocol and give free, informed and written consent Exclusion Criteria:

  • NA

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Provider of Information About this Clinical Study
    • Sponsor

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