Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Cortical bone tissue properties by reference point indentation
研究概览
简要总结
The objective of this study is to determine whether a new minimally invasive method for in vivo measurement of cortical bone tissue properties can identify those who are at risk for fragility fractures of the hip and radius. The investigators hypothesis is that women with fragility fractures of the hip and radius have altered cortical bone tissue properties compared to non-fracture controls independent of standard clinical tests, such as bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA).
详细描述
The objective of this study is to determine whether a new minimally invasive method for in vivo measurement of cortical bone tissue properties can identify those who are at risk for fragility fractures of the hip and radius. The investigators hypothesis is that women with fragility fractures of the hip and radius have altered cortical bone tissue properties compared to non-fracture controls independent of standard clinical tests, such as BMD. To test these hypotheses, The investigators propose two aims:
Aim 1: Compare cortical bone tissue properties as assessed in vivo by reference point indentation in women with hip fractures and non-fracture controls.
The investigators will compare cortical bone tissue material properties, as assessed by novel in vivo indentation at the mid-tibia in postmenopausal women with recent hip fractures (n) and age-similar controls without fractures (n=). In addition to in vivo indentation measurements, The investigators will assess hip and spine BMD by DXA; as well as other factors that may influence risk of fractures (e.g, vit D status, medication use and physical activity). Hypotheses: Postmenopausal women with hip fractures will have worse bone tissue material properties compared to non-fracture controls even after adjustment for BMD and other potential confounders.
Aim 2: Compare cortical bone tissue properties as assessed in vivo by reference point indentation in women with distal radius fractures to non-fracture controls.
The investigators will compare cortical bone tissue material properties, as assessed by novel in vivo indentation at the mid-tibia in postmenopausal women with recent distal radius fractures (n) and age-similar controls without fractures (n=). In addition to in vivo indentation measurements, The investigators will assess hip and spine BMD by DXA; as well as other factors that may influence risk of fractures (e.g, vit D status, medication use and physical activity). Hypotheses: Postmenopausal women with distal radius fractures will have worse bone tissue material properties compared to non-fracture controls even after adjustment for BMD and other potential confounders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women with hip and wrist fractures within 2 weeks of presentation
- •Non-fracture controls
排除标准
- •Unable to undergo BMD by DXA or high-resolution peripheral quantitative computed tomography (HR-pQCT)
- •History of skeletal metastasis, primary hyperparathyroidism, Paget's disease, multiple myeloma
- •Treatment with bisphosphonate, estrogen (within previous 3 years), teriparatide therapy, calcitonin, selective estrogen receptor modulator (SERMs,within previous 3 years)
- •Use of glucocorticoids continuously for more than 3 months, use of anticonvulsants
- •Prior fracture in adulthood (>age 18) for healthy controls
- •Amendment to protocol added Arm 2, to include males >50 years with otherwise similar eligibility criteria.
结局指标
主要结局
Cortical bone tissue properties by reference point indentation
时间窗: Day 1
Osteoprobe measurement
Bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA)
时间窗: Day 1
DXA at the hip and spine
次要结局
未报告次要终点
研究者
Tamara Rozental
Associate Professor, Harvard Medical School
Beth Israel Deaconess Medical Center