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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01331980
First received: March 15, 2011
Last updated: June 6, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention
Cystic Fibrosis
 Device: Peripheral quantitative computed tomography (pQCT)
Device: Dual X-ray absorptiometry (DXA)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Bone Microarchitecture at the Radius: a Pilot Comparison Between Children With Cystic Fibrosis and Healthy Controls

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Peripheral quantitative computed tomography (pQCT) - cortex width [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    pQCT scan of the non-dominant radius at the 4% and 65% sites will be conducted and parameters will include cortex width, trabecular bone mineral density (BMD), and total BMD

  • pQCT parameters - trabecular BMD [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    pQCT scan of the non-dominant radius at the 4% and 65% sites will be conducted and parameters will include cortex width, trabecular BMD, and total BMD

  • pQCT parameters - total BMD [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    pQCT scan of the non-dominant radius at the 4% and 65% sites will be conducted and parameters will include cortex width, trabecular BMD, and total BMD.


Biospecimen Retention:   Samples Without DNA

Serum samples will be frozen and assayed together.


Estimated Enrollment: 48
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cystic fibrosis
children aged 6-12 years of age and Tanner stage 1 with a diagnosis of cystic fibrosis
 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
Other Name: Stratec XCT 2000 series pQCT
Device: Dual X-ray absorptiometry (DXA)
A total body DXA scan will be conducted at a single study visit
Other Name: Hologic QDR 4500A
healthy controls
children ages 6-12 years and Tanner stage 1 without cystic fibrosis or other chronic disease that affects bone health
 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
Other Name: Stratec XCT 2000 series pQCT
Device: Dual X-ray absorptiometry (DXA)
A total body DXA scan will be conducted at a single study visit
Other Name: Hologic QDR 4500A

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants for the cystic fibrosis (CF) group will be recruited from the pulmonary clinic at Arkansas Children's Hospital. Healthy controls will be recruited from Arkansas Children's Hospital outpatient clinics and the community.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331980

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Catherine O'Brien, PharmD University of Arkansas for Medical Sciences and Arkansas Children's Hospital
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01331980     History of Changes
Other Study ID Numbers: 113442
Study First Received: March 15, 2011
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
cystic fibrosis
bone

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013