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Completed

NCT Number: NCT01837589

Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis

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).

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker Hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QCT

Other

Other names: Quantitative Computed Tomodensitometry

DXA

Other

Other names: Dual-emission X-ray

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hôpital Necker-Enfants Malades

Other

Collaborators

  • Vaincre la Mucoviscidose

Registry information

Official study title

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

Acronym: TOMODENS

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 23, 2013
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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