Evaluation of the Bone Microarchitecture in a Young Cystic Fibrosis Patients Using High-Resolution Peripheral Quantitative Computed Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Healthy volunteers
Volunteers realize a HR-pQCT scanner
干预措施: scan examination HR-pQCT (Other)
Cystic Fibrosis patient
Patients realize a HR-pQCT scanner
干预措施: scan examination HR-pQCT (Other)
结局指标
主要结局
Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography
时间窗: at the inclusion visit J0
次要结局
- Trabecular bone micro-architecture at tibia and radial sites(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(at the inclusion visit J0)
- total radial bone mass density(at the inclusion visit J0)