Peripheral Artery Disease (PAD) : Its Effects on Bone
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Bone Mineral Density (BMD) volumic values at the tibias of PAD (Peripheral Artery Disease) patients
研究概览
简要总结
Prevalence of PAD and osteoporosis (OP) both get higher with age. Clinical and epidemiologic evidence have showed an increased cardiovascular risk in OP and bone loss and fragility fractures in patient with cardiovascular disease.
This study will examine the relationship between vascular disease in legs and sBMD and vBMD at trabecular and cortical sites and bone microarchitecture.
详细描述
The primary goal of our study is to determinate if presence of PAD is associated with lower sBMD and vBMD values at the tibias, assuming that BMD should be more alterate in the predominant vascular impairement site.
Our secondary objectives are to :
- determine if severity of PAD quantified by ankle brachial index ABI is associated to a decrease of BMD values defined by T-Score at the left hip, spine and legs, but also with volumetric values, assessed by HRpQCT at the non dominant radius and at both tibias.
- determine the prevalence of osteoporosis in our population
- To evaluate the relationships between ;
- lipids and bone parameters
- vit D and parathormone with PAD severity
- levels of physical activity and both vascular and bone impairments
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAD patients defined by an Ankle brachial index < 0.9
- •Written consent
- •Patient affiliated with a social security organism
排除标准
- •Age < 18 years
- •Pregnancy or risk of pregnancy
- •Patients Under guardianship
- •Patient with known PAD who had been previously treated by surgery or endovascular pathway
结局指标
主要结局
Bone Mineral Density (BMD) volumic values at the tibias of PAD (Peripheral Artery Disease) patients
时间窗: Day 0
BMD volumic values are BMD volumetric bone mineral density (mg HA/cm3)
次要结局
- Bone Mineral Density (BMD) measurement by DXA(Day 0)
- Comparison between microstructural parameters at tibias(Day 0)
- Percentage of densitometric osteoporotic patients(Day 0)
- Correlation between Lipid and bone parameters(Day 0)
- Evaluation of cardiovascular risk(Day 0)
- Correlation between microstructural parameters at tibias and radius(Day 0)
- Correlation between microstructural parameters and ankle brachial index results(Day 0)
- Evaluation of risk of fracture(Day 0)