Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis (TOMODENS)

Evaluation of the Bone Mineralization by Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis : Validation Study

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).

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: QCT; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Necker Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: QCT and DXA; All the patients will have both QCT and DXA	Other: QCT; Other Names: Quantitative Computed Tomodensitometry; Other: DXA; Other Names: Dual-emission X-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the prevalence of osteopenia in children and adult affected by cystic fibrosis.	1 day
Correlation of bone mineralization with nutritional status (BMI)	1 day
Correlation of bone mineralization with respiratory status (FEV % predicted)	1 day
Correlation of bone mineralization with Vitamine D (25(OH)vitD)	1 day
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)	1 day

Collaborators and Investigators

• Sponsor: Hôpital Necker-Enfants Malades
• Collaborators: Vaincre la Mucoviscidose
• Investigators: Principal Investigator: Isabelle Sermet-Gaudelus, Professor, Necker Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cystic fibrosis-DXA-QCT-Osteopenia- Osteoporosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: N° ID RCB : 2009-A00292-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No