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

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.
 
ClinicalTrials.gov Identifier: NCT00006138
Recruitment Status : Completed
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
Office of Rare Diseases (ORD)

Tracking Information
First Submitted Date August 3, 2000
First Posted Date August 4, 2000
Last Update Posted Date June 24, 2005
Study Start Date June 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major
Official Title Not Provided
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.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Osteoporosis
  • Thalassemia Major
  • Osteopenia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June 23, 2005)		 35
Original Enrollment Same as current
Study Completion Date August 2000
Primary Completion Date Not Provided
Eligibility Criteria
  • Diagnosis of thalassemia major with iron overload
  • Not pregnant
  • Negative pregnancy test
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00006138
Other Study ID Numbers 199/15314
CHP-IRB-1998-6-1502
CHP-GCRC-1655
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor National Center for Research Resources (NCRR)
Original Study Sponsor Same as current
Collaborators Children's Hospital of Philadelphia
Investigators
Study Chair: Alan Richard Cohen Children's Hospital of Philadelphia
PRS Account Office of Rare Diseases (ORD)
Verification Date October 2000