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
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Other: QCT Other: DXA||Not Applicable|
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)|
|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|
QCT and DXA
All the patients will have both QCT and DXA
Other Name: Quantitative Computed Tomodensitometry
Other Name: Dual-emission X-ray
- 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)
- 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 ]
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
|Paris, France, 75014|
|Principal Investigator:||Isabelle Sermet-Gaudelus, Professor||Necker Hospital|