NCT01837589

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

3.3 years

First QC Date

November 15, 2012

Last Update Submit

February 23, 2018

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis-DXA-QCT-Osteopenia- Osteoporosis

Outcome Measures

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)

    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 Outcomes (5)

  • 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

Study Arms (1)

QCT and DXA

OTHER

All the patients will have both QCT and DXA

Other: QCTOther: DXA

Interventions

QCTOTHER
Also known as: Quantitative Computed Tomodensitometry
QCT and DXA
DXAOTHER
Also known as: Dual-emission X-ray
QCT and DXA

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient transplanted
  • Patient with an infective exacerbation phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Isabelle Sermet-Gaudelus, Professor

    Necker Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2012

First Posted

April 23, 2013

Study Start

January 1, 2012

Primary Completion

May 1, 2015

Study Completion

September 1, 2016

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)