URIPRED: Prednisolone Urinary Excretion Kinetics
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Knee infiltration Patients requiring prednisolone knee infiltration as part of routine medical management |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Pre-intervention (infiltration)]
Urinary dosing
- Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Hour24 after intervention]
Urinary dosing
- Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Hour48 after intervention]
Urinary dosing
- Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Day7 after intervention]
Urinary dosing
- Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Day14 after intervention]
Urinary dosing
- Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Day28 after intervention]
Urinary dosing
- Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Day42 after intervention]
Urinary dosing
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Male or female
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18-65 years old
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requiring intra-articular injection of prednisolone as part of routine care
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naive to any corticosteroid administration
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requiring a blood biology test as part of routine care and before the infiltration procedure
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For women of childbearing age, negative urine pregnancy test at inclusion
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Affiliated to a social health insurance plan
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Able to understand the protocol and give free, informed and written consent
Exclusion Criteria:
- NA
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Strasbourg, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8328