Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major
This study has been completed.
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00006138
First received: August 3, 2000
Last updated: June 23, 2005
Last verified: October 2000
| Tracking Information | |||||
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| First Received Date ICMJE | August 3, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | June 1998 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00006138 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Primary Purpose: Screening | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 35 | ||||
| Completion Date | August 2000 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||
| Ages | 6 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00006138 | ||||
| Other Study ID Numbers ICMJE | 199/15314, CHP-IRB-1998-6-1502, CHP-GCRC-1655 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | Children's Hospital of Philadelphia | ||||
| Investigators ICMJE |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | October 2000 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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