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

This study has been completed.

First Received: August 3, 2000 Last Updated: June 23, 2005 History of Changes

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

Study Type:	Observational
Study Design:	Screening

Resource links provided by NLM:

Genetics Home Reference related topics: beta thalassemia

MedlinePlus related topics: Osteoporosis Thalassemia

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

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

Additional relevant MeSH terms:

Anemia, Hemolytic, Congenital
Musculoskeletal Diseases
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Beta-Thalassemia

Anemia
Anemia, Hemolytic
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Thalassemia

ClinicalTrials.gov processed this record on July 02, 2009