Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367725
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the systemic exposure to dexamethason in childhood acute lymphatic leukemia ALL The main questions it aims to answer are
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None