Understanding how dexamethasone affects children with leukemia and their bone health
Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
This study looks at how the medication dexamethasone affects bone health in children with leukemia by checking their bone density and medication levels over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 4 sites (Aalborg, Aalborg and 3 other locations) |
| Trial ID | NCT06367725 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the systemic exposure to dexamethasone in children diagnosed with acute lymphoblastic leukemia (ALL) and its correlation with bone mineral density. Participants will continue receiving standard therapy while providing blood and cerebrospinal fluid samples to measure dexamethasone levels. Additionally, they will undergo DXA scans at multiple time points to assess bone density and potential vertebral fractures. The study seeks to understand the relationship between dexamethasone exposure and bone health in this pediatric population.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 to 17.9 years who have been diagnosed with acute lymphoblastic leukemia.
Not a fit: Patients with Down syndrome will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could lead to improved management of dexamethasone therapy in children with ALL, potentially reducing the risk of bone density loss.
How similar studies have performed: While this study focuses on a specific population and drug interaction, similar studies have shown the importance of monitoring medication effects on bone health in pediatric cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of acute lymphoblastic leukaemia * Age 1-17.9 years Exclusion Criteria: * Down syndrome
Where this trial is running
Aalborg, Aalborg and 3 other locations
- Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital — Aalborg, Aalborg, Denmark (Recruiting)
- Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital — Aarhus N, Aarhus N, Denmark (Recruiting)
- Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet — Copenhagen, København Ø, Denmark (Recruiting)
- Department of Paediatrics and Adolescent Medicine, Odense University Hospital — Odense, Odense C, Denmark (Recruiting)
Study contacts
- Principal investigator: Birgitte K Albertsen, Professor — Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
- Study coordinator: Birgitte K Albertsen, Professor
- Email: biralber@rm.dk
- Phone: +45 2022 4643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.