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

Tracking Information

First Received Date ^ICMJE

August 3, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

June 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006138 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening

Condition ^ICMJE

Osteoporosis
Thalassemia Major
Osteopenia

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00006138

Responsible Party

Study ID Numbers ^ICMJE

199/15314, CHP-IRB-1998-6-1502, CHP-GCRC-1655

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

Children's Hospital of Philadelphia

Investigators ^ICMJE

Study Chair:

Alan Richard Cohen

Children's Hospital of Philadelphia

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

October 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP