NCT02551315已完成不适用
Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes: the DiabOS Study
University Hospital, Basel, Switzerland5 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2016年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 5
- 主要终点
- Intra-cortical pore volume
研究概览
简要总结
This multicenter, prospective, observational cohort study will assess bone differences in women and men with type 2 diabetes mellitus (T2DM) with and without fragility fractures.
详细描述
Cross-sectional evaluation of clinical, biochemical and microstructural measures of bone in patients with type 2 diabetes and age-matched healthy controls. Longitudinal assessment of clinical, biochemical and microstructural measures of bone in study participants without prevalent fragility fractures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes)
排除标准
- •immobility
- •coexisting metabolic bone disease or comorbidities affecting bone health
- •previous treatment with osteoporosis medication or intake of medications known to affect bone metabolism (e.g. steroids) within 6 months prior to enrolment
- •thiazolidinedione use
结局指标
主要结局
Intra-cortical pore volume
时间窗: 2 years
Intracortical pore volume using HR-QCT femoral shaft and mid-tibia and HR-pQCT at the distal radius (mm3)
次要结局
- advanced glycation end products (AGE)(2 years)
- Occurence of fractures during follow up(2 years)
- Areal Bone Mineral Density (aBMD)(2 years)
- Volumetric Bone Mineral Densitiy (vBMD)(2 years)
- bone turnover markers(2 years)
- Cortical thickness and porosity(2 years)
研究者
Christian Meier
Prof. Dr. med.
University Hospital, Basel, Switzerland
研究点 (5)
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