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Bone Microarchitecture at the Radius: a Pilot Comparison Between Children With Cystic Fibrosis and Healthy Controls

NCT01331980 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2015-07-03

No results posted yet for this study

Summary

Cystic fibrosis (CF) affects an estimated 30,000 people in the United States and is caused by a mutation in the gene encoding a protein called CF transmembrane regulator (CFTR). The hallmarks of CF are recurrent pulmonary exacerbations and declining pulmonary function. However, there are other problems in CF that affect both health and quality of life. These include CF related diabetes, liver disease, and bone disease. The median age of survival for patients with CF has been increasing steadily and is currently more than 37 years. With this improvement in life expectancy, it has become increasingly important to address the long-term complications of CF.

Currently, patients with CF are evaluated annually for bone disease with dual X-ray absorptiometry (DXA), and screening usually starts at age 12. However, this may not be sufficient to detect early bone changes that may impact fracture risk. Furthermore, bone disease in children may manifest earlier than adolescence, which would suggest that screening should start at an earlier age in these vulnerable patients. The following study is therefore proposed to examine the potential role of peripheral quantitative computed tomography (pQCT) as a screening approach for bone disease in children with CF. The investigators expect to find bone problems by pQCT but not DXA.

Conditions

Interventions

DEVICE

Peripheral quantitative computed tomography (pQCT)

A pQCT scan of the non-dominant radius at the 4% and 65% sites will be conducted at a single study visit

DEVICE

Dual X-ray absorptiometry (DXA)

A total body DXA scan will be conducted at a single study visit

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Catherine O'Brien, PharmD · University of Arkansas for Medical Sciences and Arkansas Children's Hospital

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01331980 on ClinicalTrials.gov