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Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis (TOMODENS)

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ClinicalTrials.gov Identifier: NCT01837589
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
Vaincre la Mucoviscidose
Information provided by (Responsible Party):
Isabelle Sermet-Gaudelus, Hôpital Necker-Enfants Malades

Brief Summary:
The purpose of this study is to conduct a comparative study for the study of bone mineralization evaluated with Quantitative computed tomodensitometry (QCT) compared to the reference technique, Dual-emission X-ray absorptiometry (DXA).

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: QCT Other: DXA Not Applicable

Detailed Description:

Patients with cystic fibrosis can have a deficit in bone mineralization. This is particularly well described in adults. However, in the pediatric population the results are more heterogeneous. The evaluation is hindered by difficulties in standardization of DXA interpretation.

This measurement depends from the mass and size of the bone as well as the mass of soft tissue covering the bone area. These two characteristics, intrinsic to the measurement, pose a significant problem of interpretations in children because a change in bone density may reflect both a change in bone mineral content or changes related to growth, for example, the increase in bone size or volume of soft tissue covering the bone of interest.

Quantitative computed tomography (QCT) provides a direct measure of bone mineralization densitometry volume. It quantifies bone mineral content in relation to the volume of the bone, in reference to an external phantom. This method therefore overcomes the size size.

This technique can be considered without an additional radiation exposure to patients during a lung CT because it is usual that lumbar vertebrae are included in the measurement window because of pulmonary hyperinflation. This exam would be ideal for patients with Cystic fibrosis.

All patients have these two evaluations during their routine management. This study compare study on the bone mineralization evaluated by (QCT) compared to the reference technique by (DXA) for the patient affected by cystic fibrosis for each patient.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Bone Mineralization by Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis : Validation Study
Actual Study Start Date : January 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
QCT and DXA
All the patients will have both QCT and DXA
Other: QCT
Other Name: Quantitative Computed Tomodensitometry

Other: DXA
Other Name: Dual-emission X-ray




Primary Outcome Measures :
  1. Evaluation of the mineralization with DXA(Dual-energy X-ray absorptiometry) as a Zscore of Bone mineral density and the Zscore of QCT (Quantitative computed tomography) [ Time Frame: 1 day ]
    Evaluation of the mineralization with DXA(Dual-energy X-ray absorptiometry) as a Zscore of Bone mineral density(reference population: same sex, same bone age) and the Zscore of QCT (Quantitative computed tomography) (reference population: same sex, same age)


Secondary Outcome Measures :
  1. Evaluation of the prevalence of osteopenia in children and adult affected by cystic fibrosis. [ Time Frame: 1 day ]
  2. Correlation of bone mineralization with nutritional status (BMI) [ Time Frame: 1 day ]
  3. Correlation of bone mineralization with respiratory status (FEV % predicted) [ Time Frame: 1 day ]
  4. Correlation of bone mineralization with Vitamine D (25(OH)vitD) [ Time Frame: 1 day ]
  5. Correlation of bone mineralization with the amount of total inhaled and oral corticosteroids administered (total number of days of steroids according to diiferent modalities: inhaled, oral IV) [ Time Frame: 1 day ]


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients affected by cystic fibrosis
  • Aged over 5 years
  • Patients whose clinical condition warrants an indication of chest CT in relation to the criteria of the french consensus conference on Cystic fibrosis in May 2002 (Palace of the Luxembourg).
  • Patients whose clinical condition warrants an indication of DXA examination in accordance with French recommendations (Consensus of the Working Group "bone mineralization and cystic fibrosis" In children, the examination is recommended for ages 8 every 2 years if the Z-score is greater than - 1, every year if the Z-score is less than - 1.. In adults, the exam is recommended every 5 years if the T-score is greater than> - 1, every 2 years if it is between -1 and - 2; annually if less than - 2.)
  • Patient does not exhibit a phase of bronchial exacerbation
  • Collection of non-opposition of the patient
  • Patient affiliated to social security

Exclusion Criteria:

  • Patient transplanted
  • Patient with an infective exacerbation phase

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837589


Locations
France
Necker Hospital
Paris, France, 75014
Sponsors and Collaborators
Hôpital Necker-Enfants Malades
Vaincre la Mucoviscidose
Investigators
Principal Investigator: Isabelle Sermet-Gaudelus, Professor Necker Hospital

Responsible Party: Isabelle Sermet-Gaudelus, Professor, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier: NCT01837589     History of Changes
Other Study ID Numbers: N° ID RCB : 2009-A00292-55
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Isabelle Sermet-Gaudelus, Hôpital Necker-Enfants Malades:
Cystic fibrosis-DXA-QCT-Osteopenia- Osteoporosis

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