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 28, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography [ Time Frame: at the inclusion visit J0 ]
- total radial bone mass density [ Time Frame: at the inclusion visit J0 ]
- Trabecular bone micro-architecture at tibia and radial sites [ Time Frame: at the inclusion visit J0 ]
- 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 ]
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
|Bron, France, 69677|