Study of Factors Associated With the Volumetric and Areal Bone Mineral Density and Bone Strength in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)
研究概览
简要总结
Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk of fracture, particularly hip fracture whose complications and postoperative mortality appear to be higher than in the general population.
This increased risk of fracture is due partly to an increased risk of falling, and secondly to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis concluded that patients with IPD have lower BMD than healthy controls. Prospective studies also showed rapid bone loss in these patients compared with controls. The association between low BMD and IPD seems dependent on the severity and duration of the disease even if some data are contradictory. Various mechanisms may explain this bone loss including weight loss, malnutrition and a low level of physical activity. However, enrollments in these studies are often weak and it is difficult to conclude on the real impact of these factors on bone loss in the IPD. The main objective of our study is to assess and prioritize from these various bone loss mechanisms. Bone assessment by "peripheral quantitative computed tomography" (pQCT) will also assess the impact of various risk factors on bone strength parameters. The prevalence of vertebral compression fractures in the IPD, at this day unknown can be evaluated. This study will also estimate the prevalence of vertebral compression fractures in the IPD.
详细描述
Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk of fracture, particularly hip fracture whose complications and postoperative mortality appear to be higher than in the general population.
This increased risk of fracture is due partly to an increased risk of falling, and secondly to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis concluded that patients with IPD have lower BMD than healthy controls. Prospective studies also showed rapid bone loss in these patients compared with controls. The association between low BMD and IPD seems dependent on the severity and duration of the disease even if some data are contradictory. Various mechanisms may explain this bone loss including weight loss, malnutrition and a low level of physical activity. However, enrollments in these studies are often weak and it is difficult to conclude on the real impact of these factors on bone loss in the IPD. The main objective of our study is to assess and prioritize from these various bone loss mechanisms. Bone assessment by "peripheral quantitative computed tomography" (pQCT) will also assess the impact of various risk factors on bone strength parameters. The prevalence of vertebral compression fractures in the IPD, at this day unknown can be evaluated. This study will also estimate the prevalence of vertebral compression fractures in the IPD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic parkinson's disease (UKPDSBB criteria)
- •Hoen and Yahr score < 4 (ON periods)
- •Age between 35 and 70 years old
- •Independent person at home
排除标准
- •Dementia patient and progressive mental illness
- •Patient with severe tremor
- •Incapacity to walk over ten minutes
- •Treatment influencing bone metabolism
- •Disease influencing phosphocalcic metabolism
- •Severe comorbidities
- •Pregnant woman
结局指标
主要结局
Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)
时间窗: at day 1
次要结局
- Bone mineral density of the lumbar spine and hip measured by DXA(at day 1)
- Vertebral fracture assessment (VFA)(at day 1)
- Trabecular and cortical bone mineral density of the tibia and the radius(at day 1)
- body composition by DXA(at day 1)
- Bone turnovers markers (CTX), 25 OH vitamin D(at day 1)
- Trabecular bone score of the lumbar spine(at day 1)
- Parkinson's disease score(at day 1)
- Architectural parameters and bone resistance of the tibia and radius measured by pQCT(at day 1)
- Axial muscular area of the tibia and radius measured by pQCT(at day 1)