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OpenTrials
Completed

NCT Number: NCT01788267

Bone Microarchitecture in Young Cystic Fibrosis Patients

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme-Mère-Enfant

Bron, 69677, France

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

scan examination HR-pQCT

Other

Primary outcomes

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

    Time frame: at the inclusion visit J0

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 11, 2013
Registry last updated
May 28, 2019

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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