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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
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

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

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Diagnosis of thalassemia major with iron overload Not pregnant Negative pregnancy test

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Children's Hospital of Philadelphia
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    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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