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Bone Microarchitecture in Young Cystic Fibrosis Patients

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
scan examination HR-pQCT
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, High-Resolution peripheral Quantitative Computed Tomography, Bone Mass Density

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Femme-Mère-Enfant

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy volunteers

Cystic Fibrosis patient

Arm Description

Volunteers realize a HR-pQCT scanner

Patients realize a HR-pQCT scanner

Outcomes

Primary Outcome Measures

Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography

Secondary Outcome Measures

total radial bone mass density
Trabecular bone micro-architecture at tibia and radial sites
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

Full Information

First Posted
February 5, 2013
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01788267
Brief Title
Bone Microarchitecture in Young Cystic Fibrosis Patients
Official Title
Evaluation of the Bone Microarchitecture in a Young Cystic Fibrosis Patients Using High-Resolution Peripheral Quantitative Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, High-Resolution peripheral Quantitative Computed Tomography, Bone Mass Density

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Volunteers realize a HR-pQCT scanner
Arm Title
Cystic Fibrosis patient
Arm Type
Experimental
Arm Description
Patients realize a HR-pQCT scanner
Intervention Type
Other
Intervention Name(s)
scan examination HR-pQCT
Primary Outcome Measure Information:
Title
Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography
Time Frame
at the inclusion visit J0
Secondary Outcome Measure Information:
Title
total radial bone mass density
Time Frame
at the inclusion visit J0
Title
Trabecular bone micro-architecture at tibia and radial sites
Time Frame
at the inclusion visit J0
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital Femme-Mère-Enfant
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28795206
Citation
Braun C, Bacchetta J, Braillon P, Chapurlat R, Drai J, Reix P. Children and adolescents with cystic fibrosis display moderate bone microarchitecture abnormalities: data from high-resolution peripheral quantitative computed tomography. Osteoporos Int. 2017 Nov;28(11):3179-3188. doi: 10.1007/s00198-017-4179-9. Epub 2017 Aug 9.
Results Reference
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Bone Microarchitecture in Young Cystic Fibrosis Patients

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