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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.
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00006138
First received: August 3, 2000
Last updated: June 23, 2005
Last verified: October 2000
History of Changes
  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

Study Type: Observational
Study Design: Primary Purpose: Screening

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00006138     History of Changes
Other Study ID Numbers: 199/15314, CHP-IRB-1998-6-1502, CHP-GCRC-1655
Study First Received: August 3, 2000
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Beta-Thalassemia
Bone Diseases, Metabolic
Osteoporosis
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013