Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bone Microarchitecture in Young Cystic Fibrosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01788267
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: scan examination HR-pQCT Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Bone Microarchitecture in a Young Cystic Fibrosis Patients Using High-Resolution Peripheral Quantitative Computed Tomography
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography [ Time Frame: at the inclusion visit J0 ]

Secondary Outcome Measures :
  1. total radial bone mass density [ Time Frame: at the inclusion visit J0 ]
  2. Trabecular bone micro-architecture at tibia and radial sites [ Time Frame: at the inclusion visit J0 ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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): NCT01788267


Locations
Layout table for location information
France
Hôpital Femme-Mère-Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon

Publications of Results:
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01788267     History of Changes
Other Study ID Numbers: 2011.678
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2015
Keywords provided by Hospices Civils de Lyon:
Cystic Fibrosis
High-Resolution peripheral Quantitative Computed Tomography
Bone Mass Density
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases