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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:
ClinicalTrials.gov Identifier:
NCT00006138
First Posted: August 4, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
Office of Rare Diseases (ORD)
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Diagnosis of thalassemia major with iron overload
  • Not pregnant
  • Negative pregnancy test
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00006138     History of Changes
Other Study ID Numbers: 199/15314
CHP-IRB-1998-6-1502
CHP-GCRC-1655
First Submitted: August 3, 2000
First Posted: August 4, 2000
Last Update Posted: December 9, 2005
Last Verified: October 2000

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:
Osteoporosis
Thalassemia
Bone Diseases, Metabolic
beta-Thalassemia
Bone Diseases
Musculoskeletal Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn