Bone Microarchitecture at the Radius: a Pilot Comparison Between Children With Cystic Fibrosis and Healthy Controls
Completed
Conditions studied: Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT01331980
- Run by
- University of Arkansas
- People needed
- 39
- Starts
- 2011-01-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2015-07-03
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Diagnosis of CF by sweat test and/or genotyping for CF subjects (for CF group only)
- 6-12 years of age at time of study visit
- Body mass index of at least the 3rd percentile
- Tanner stage 1
You may not qualify if…
- Body mass index (BMI) greater than the 95th percentile
- Recent fracture (within the past 6 months)
- Lung transplant recipient
- Current pulmonary exacerbation or current infection
- History of bisphosphonate or growth hormone therapy (in the past 5 years)
- Glucocorticoid therapy within the past 6 months
- Severe pulmonary dysfunction (forced expiratory volume in 1 second < 40% predicted) if subjects are performing spirometry
- Concomitant disease known to cause bone disease (e.g. chronic kidney disease, CF-related diabetes)
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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