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

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006138
• Other study ID #: 199/15314
• Secondary ID: CHP-IRB-1998-6-1
• Status: Completed
• Phase: N/A
• First received: August 3, 2000
• Last updated: June 23, 2005
• Start date: June 1998
• Est. completion date: August 2000

Study information

• Verified date: October 2000
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

• Diagnosis of thalassemia major with iron overload

• Not pregnant

• Negative pregnancy test

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Beta-Thalassemia
• Osteopenia
• Osteoporosis
• Thalassemia
• Thalassemia Major

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Children's Hospital of Philadelphia