Prednisolone Urinary Excretion Kinetics

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee

Conditions
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Articular Cartilage Disorder of Knee

Intervention / Treatment
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* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee infiltration<br>Patients requiring prednisolone knee infiltration as part of routine medical management | Drug: Prednisolone<br>* 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.<br>* Other names: Infiltration;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Doping, Prednisolone, Pharmacokinetics, Pharmacogenetics