NCT06069089

Brief Summary

Bone denisty changes in children with beta thalassemia major

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 29, 2023

Last Update Submit

September 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate bone denisty in children with beta thalassemia major

    To evaluate bone denisty in transfusion dependent beta thalassemia major \& its relation to serum minerals \&vit D To evaluate bone denisity in transfusion dependent beta thalassemia major \& its relation to serum minerals \&vit D To evaluate bone denisity in transfusion dependent beta thalassemia major \&its relation to serrum minerals \&vitD

    One year

Study Arms (2)

Controlled beta thalassemia major

Controlled beta thalassemia major Hb\>9g/dl , serum ferritin \<500ng/ml

Radiation: Dexa scan

Uncontrolled beta thalassemia major

Uncontrolled beta thalassemia major Hb\<9g/dl , serum ferritin \>500ng/ml

Radiation: Dexa scan

Interventions

Dexa scanRADIATION

No intervention

Controlled beta thalassemia majorUncontrolled beta thalassemia major

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with beta thalassemia major with transfusion dependent

You may qualify if:

  • \- Patient diagnosed as B thalassemia major of both sexes, age range from 10-18 year, who are poorly controlled on frequant blood transfusion. The patient who doesn't have Hb level from 9-10 g/dl, in almost always less than 9 g/dl.

You may not qualify if:

  • Known metabolic bone disease. Less than 10 year or more than 18 year. Bone disease Other than hemolytic anemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gaudio A, Morabito N, Catalano A, Rapisarda R, Xourafa A, Lasco A. Pathogenesis of Thalassemia Major-associated Osteoporosis: A Review with Insights from Clinical Experience. J Clin Res Pediatr Endocrinol. 2019 May 28;11(2):110-117. doi: 10.4274/jcrpe.galenos.2018.2018.0074. Epub 2018 Jul 11.

    PMID: 29991466BACKGROUND

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assiut university , pediatrician department

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 5, 2023

Study Start

December 15, 2023

Primary Completion

December 15, 2024

Study Completion

December 31, 2024

Last Updated

October 5, 2023

Record last verified: 2023-09