Bone Microarchitecture in Young Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788267
• Other study ID #: 2011.678
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• scan examination HR-pQCT

Locations

Country	Name	City	State
France	Hôpital Femme-Mère-Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography		at the inclusion visit J0
Secondary	total radial bone mass density		at the inclusion visit J0
Secondary	Trabecular bone micro-architecture at tibia and radial sites		at the inclusion visit J0
Secondary	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		at the inclusion visit J0