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Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Children's Hospital of Philadelphia
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00006138
  Purpose

OBJECTIVES:

I. Determine the frequency and severity of osteopenia and osteoporosis in patients with thalassemia major who undergo dual energy x-ray absorptiometry, and correlate these findings with other relevant endocrinologic measurements.


Condition
Osteoporosis
Thalassemia Major
Osteopenia

Genetics Home Reference related topics:   beta thalassemia   

MedlinePlus related topics:   Osteoporosis    Thalassemia   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:   35
Study Start Date:   June 1998
Estimated Study Completion Date:   August 2000

Detailed Description:

PROTOCOL OUTLINE:

Patients undergo dual energy x-ray absorptiometry for bone density measurements, height (sitting and standing) and weight measurements, comprehensive endocrinologic examination, and assessment of the severity of iron overload at baseline, and then at years 1 and 2.

  Eligibility
Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • Diagnosis of thalassemia major with iron overload
  • Not pregnant
  • Negative pregnancy test
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006138

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Children's Hospital of Philadelphia

Investigators
Study Chair:     Alan Richard Cohen     Children's Hospital of Philadelphia    
  More Information


Study ID Numbers:   199/15314, CHP-IRB-1998-6-1502, CHP-GCRC-1655
First Received:   August 3, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00006138
Health Authority:   United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
disease-related problem/condition  
genetic diseases and dysmorphic syndromes  
hematologic disorders  
osteoporosis
rare disease
thalassemia major

Study placed in the following topic categories:
Hematologic Diseases
Beta-thalassemia
Rare Diseases
Anemia
Osteoporosis
Anemia, Hemolytic
Bone Diseases, Metabolic
Thalassemia
Bone Diseases
Anemia, Hemolytic, Congenital
Thalassemia minor
Genetic Diseases, Inborn
Musculoskeletal Diseases
Beta-Thalassemia
Hemoglobinopathies
Hemoglobinopathy

ClinicalTrials.gov processed this record on October 03, 2008




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