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

April 11, 2024 updated by: University of Aarhus

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Birgitte K Albertsen, Professor
  • Phone Number: +45 2022 4643
  • Email: biralber@rm.dk

Study Contact Backup

  • Name: Karen S Jensen, phd
  • Phone Number: +45 61718432
  • Email: kascje@rm.dk

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Not yet recruiting
        • Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital
        • Contact:
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
        • Contact:
        • Contact:
          • Birgitte K Albertsen, Professor
    • København Ø
      • Copenhagen, København Ø, Denmark, 2100
        • Not yet recruiting
        • Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet
        • Contact:
    • Odense C
      • Odense, Odense C, Denmark, 5000
        • Not yet recruiting
        • Department of Paediatrics and Adolescent Medicine, Odense University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents diagnosed with ALL and treated according to the established and approved treatment protocol in Denmark

Description

Inclusion Criteria:

  • A diagnosis of acute lymphoblastic leukaemia
  • Age 1-17.9 years

Exclusion Criteria:

  • Down syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Plasma Concentration Curve (AUC) of Dexamethasone
Time Frame: Repeated during induction, with AUC measurements on days 3, 4, and 15. Blood samples taken before dosing, and after 1, 2, 4, and 6 hours
Blood samples
Repeated during induction, with AUC measurements on days 3, 4, and 15. Blood samples taken before dosing, and after 1, 2, 4, and 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mineral bone density by DXA-scan
Time Frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
DXA-scan
Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Vertebral fracture assessment (VFA) by DXA-scan
Time Frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
DXA-scan
Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Dexamethasone in cerebrospinal fluid
Time Frame: When lumbar punctures are performed according to standard treatment during induction
Comparing measurements of dexamethasone in blood and cerebrospinal fluid
When lumbar punctures are performed according to standard treatment during induction

Other Outcome Measures

Outcome Measure
Time Frame
Physical activity questionnaire
Time Frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Biomarkers of bone metabolism
Time Frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Birgitte K Albertsen, Professor, Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-122-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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