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Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis (TOMODENS)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QCT
DXA
Sponsored by
Hôpital Necker-Enfants Malades
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring Cystic fibrosis-DXA-QCT-Osteopenia- Osteoporosis

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Necker Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

QCT and DXA

Arm Description

All the patients will have both QCT and DXA

Outcomes

Primary Outcome Measures

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)
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

Evaluation of the prevalence of osteopenia in children and adult affected by cystic fibrosis.
Correlation of bone mineralization with nutritional status (BMI)
Correlation of bone mineralization with respiratory status (FEV % predicted)
Correlation of bone mineralization with Vitamine D (25(OH)vitD)
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)

Full Information

First Posted
November 15, 2012
Last Updated
February 23, 2018
Sponsor
Hôpital Necker-Enfants Malades
Collaborators
Vaincre la Mucoviscidose
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1. Study Identification

Unique Protocol Identification Number
NCT01837589
Brief Title
Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis
Acronym
TOMODENS
Official Title
Evaluation of the Bone Mineralization by Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis : Validation Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Necker-Enfants Malades
Collaborators
Vaincre la Mucoviscidose

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic fibrosis-DXA-QCT-Osteopenia- Osteoporosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QCT and DXA
Arm Type
Other
Arm Description
All the patients will have both QCT and DXA
Intervention Type
Other
Intervention Name(s)
QCT
Other Intervention Name(s)
Quantitative Computed Tomodensitometry
Intervention Type
Other
Intervention Name(s)
DXA
Other Intervention Name(s)
Dual-emission X-ray
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Evaluation of the prevalence of osteopenia in children and adult affected by cystic fibrosis.
Time Frame
1 day
Title
Correlation of bone mineralization with nutritional status (BMI)
Time Frame
1 day
Title
Correlation of bone mineralization with respiratory status (FEV % predicted)
Time Frame
1 day
Title
Correlation of bone mineralization with Vitamine D (25(OH)vitD)
Time Frame
1 day
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Sermet-Gaudelus, Professor
Organizational Affiliation
Necker Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis

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