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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
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 July 29, 2014