Bone Denisty Change in Children With Beta Thalassemia Major
Assiut University, Pediatrician Department
1 other identifier
observational
42
0 countries
N/A
Brief Summary
Bone denisty changes in children with beta thalassemia major
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedStudy Start
First participant enrolled
December 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 5, 2023
September 1, 2023
1 year
September 29, 2023
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
Uncontrolled beta thalassemia major
Uncontrolled beta thalassemia major Hb\<9g/dl , serum ferritin \>500ng/ml
Interventions
No intervention
Eligibility Criteria
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
- Marwa Hassan Abdelhamed Hassanlead
- Assiut Universitycollaborator
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
Intervention Hierarchy (Ancestors)
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