Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major
Primary Purpose
Osteoporosis, Thalassemia Major, Osteopenia
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Osteoporosis focused on measuring disease-related problem/condition, genetic diseases and dysmorphic syndromes, hematologic disorders, osteoporosis, rare disease, thalassemia major
Eligibility Criteria
Diagnosis of thalassemia major with iron overload Not pregnant Negative pregnancy test
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006138
First Posted
August 3, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00006138
Brief Title
Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major
Study Type
Observational
2. Study Status
Record Verification Date
October 2000
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Children's Hospital of Philadelphia
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Thalassemia Major, Osteopenia
Keywords
disease-related problem/condition, genetic diseases and dysmorphic syndromes, hematologic disorders, osteoporosis, rare disease, thalassemia major
7. Study Design
Enrollment
35 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis of thalassemia major with iron overload
Not pregnant
Negative pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Richard Cohen
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major
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