Clinical trial NCT01788267: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
High-Resolution peripheral Quantitative Computed Tomography
Bone Mass Density
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 38
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography
timeFrame: at the inclusion visit J0
Secondary outcomes:
measure: total radial bone mass density
timeFrame: at the inclusion visit J0
measure: Trabecular bone micro-architecture at tibia and radial sites
timeFrame: at the inclusion visit J0
measure: 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
timeFrame: at the inclusion visit J0
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant
Study officials:
References:
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.