This trial is active, not recruiting.

Condition cystic fibrosis
Treatments qct, dxa
Sponsor Hôpital Necker-Enfants Malades
Collaborator Vaincre la Mucoviscidose
Start date January 2012
End date May 2015
Trial size 131 participants
Trial identifier NCT01837589, N° ID RCB : 2009-A00292-55


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
All the patients will have both QCT and DXA
qct Quantitative Computed Tomodensitometry
dxa Dual-emission X-ray

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 5 years old.

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

Additional Information

Official title Evaluation of the Bone Mineralization by Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis : Validation Study
Principal investigator Isabelle Sermet-Gaudelus, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hôpital Necker-Enfants Malades.