Bone Microarchitecture in Young Cystic Fibrosis Patients

May 23, 2019 updated by: Hospices Civils de Lyon

Evaluation of the Bone Microarchitecture in a Young Cystic Fibrosis Patients Using High-Resolution Peripheral Quantitative Computed Tomography

Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD) potentially leading to pathological fractures at adult age. Recent data from our center and others have suggested that low BMD could be observed very early in life. However, quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength).

High-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology with very high spatial resolution. Images obtained with this technic are considered as virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces exploration in a three-dimensional manner, and therefore provides informations on bone microarchitecture as well as bone density.

The aim of this study is to evaluate bone microarchitecture of paediatric patients matched to sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore potential correlations HR-pQCT parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hôpital Femme-Mère-Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cystic Fibrosis patient of both sex
  • Pubertal patient
  • Age ≥10 years and ≤18 years on the date of informed consent
  • FEV1(forced expiratory volume at one second ) ≥ 60% of predicted normal for age, gender and height
  • Patient on a clinical stable period

Exclusion Criteria:

  • Unable to maintain arm and/or leg immobile for 3 minutes
  • History of solid organ transplantation
  • Participation in the same time to a clinical trial
  • Acute pulmonary exacerbation at the time of evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy volunteers
Volunteers realize a HR-pQCT scanner
Other: scan examination HR-pQCT
EXPERIMENTAL: Cystic Fibrosis patient
Patients realize a HR-pQCT scanner
Other: scan examination HR-pQCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography
Time Frame: at the inclusion visit J0
at the inclusion visit J0

Secondary Outcome Measures

Outcome Measure
Time Frame
total radial bone mass density
Time Frame: at the inclusion visit J0
at the inclusion visit J0
Trabecular bone micro-architecture at tibia and radial sites
Time Frame: at the inclusion visit J0
at the inclusion visit J0
Biological markers : 1) bone markers : parathyroid hormone (PTH), Calcifediol (25(OH)D3), osteocalcin, Endocrinal markers : IGF-1 (insulin like growth factor ), IGFBP-3, leptin, adiponectin, visfatin, resistin
Time Frame: at the inclusion visit J0
at the inclusion visit J0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (ESTIMATE)

February 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.678

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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