Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• A diagnosis of acute lymphoblastic leukaemia

• Age 1-17.9 years

Locations
Other Locations
Denmark
Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
RECRUITING
Aarhus N
Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Department of Paediatrics and Adolescent Medicine, Odense University Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Birgitte K Albertsen, Professor
biralber@rm.dk
+45 2022 4643
Backup
Karen S Jensen, phd
kascje@rm.dk
+45 61718432
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 100
Sponsors
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov

Similar Clinical Trials