Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
NCT ID: NCT06367725
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-04-11
2030-12-30
Brief Summary
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* How does the intake of dexamethasone correlate with systemic exposure to dexamethason?
* Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?
Participants will:
* Continue to receive the best available therapy for ALL in Western Europe.
* Have blood samples taken from their central line to measure dexamethasone levels.
* When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.
* Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age 1-17.9 years
Exclusion Criteria
1 Year
17 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Birgitte K Albertsen, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
Locations
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Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet
Copenhagen, København Ø, Denmark
Department of Paediatrics and Adolescent Medicine, Odense University Hospital
Odense, Odense C, Denmark
Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital
Aalborg, , Denmark
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus N, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Birgitte K Albertsen, Professor
Role: backup
Other Identifiers
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1-10-72-122-23
Identifier Type: -
Identifier Source: org_study_id
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