A Cross-sectional, Single-cohort, Bi-centre Clinical Investigation to Estimate Surrogate Bone Mineral Density (BMD) in Young and Middle-aged Men and Women Using Quantitative Ultrasound Imaging (POROUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 6
- 主要终点
- Primary Clinical Endpoint - POROUS
研究概览
简要总结
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break. Osteoporosis and bone fracture risk are currently evaluated by looking at clinical risk factors and measuring bone mineral density (BMD). The lower the BMD is, the higher the risk of osteoporotic fractures in the future. An X-ray device called DXA is the main tool used to diagnose osteoporosis and fracture risk clinically. DXA measures two-dimensional BMD in the hip and spine. However, DXA devices are often not readily available at the point of care.
The POROUS ultrasound device offers a different approach by measuring various properties of the outer layer of the bone in the lower leg. It has several advantages over DXA: (1) higher and three-dimensional image resolution; (2) the ability to measure bone properties without radiation; (3) portability, it is a mobile medical device; 4) lower operational costs.
For this clinical study, we will recruit men and women between the ages of 21 and 55. Most of these study participants will not have evident clinical risks for osteoporosis. The goal for including this age group is to estimate the range of BMD values for younger people before BMD declines with age. In a separate clinical study, we are recruiting older participants. The study is anticipated to last one year.
Our major research questions are:
- Can the POROUS ultrasound device estimate BMD?
- How does its performance compare to DXA?
- What is the safety of the new device?
The participants will:
- answer questions about their medical history.
- be measured for height and weight.
- be examined with the two devices, DXA and POROUS.
详细描述
Medical background and current standard of care:
Osteoporosis is defined as a systemic skeletal disease characterized by low mineral bone mass and microarchitectural deterioration of bone tissue (Consensus Conference, 1994). This increased bone fragility is associated with susceptibility to fractures, which have substantial economic and societal burdens. Osteoporosis is routinely diagnosed through bone density assessments; however, there is a shortage of accurate means to characterize bone microstructure for diagnostic purposes. The POROUS R4C ultrasound device is capable of providing such information in detail.
The current standard of care (SoC) physical bone parameter for examining bone health is areal BMD (aBMD), typically measured by dual-energy X-ray absorptiometry (DXA) at the hip or spine. Scaling is given to score the patient's aBMD in comparison to a reference of a healthy bone. The resulting T Score compares the patient's aBMD to the peak aBMD of young adults of the same sex, while the Z score compares it to the average aBMD of the same age and sex. According to the operational WHO definition (1994), a T Score of -1.0 or above is considered normal, while scores between -1.0 and -2.5 indicate osteopenia, and scores of -2.5 or lower indicate osteoporosis.
The rationale for the clinical investigation:
Quantitative ultrasound (QUS) devices have several substantial advantages over X-ray-based technologies: a better safety profile (non-ionizing radiation), cost-efficiency, usability, and portability. These advantages can result in improved accessibility at point-of-care. The major challenge is, nonetheless, clinical performance. QUS devices that assess bone health have demonstrated varying performance in estimating surrogate aBMD values. aBMD estimation is calculated by empirical correlation with DXA reference measurements using a combination of ultrasound parameters and anthropometric information. We follow these clinical performance standards for aBMD estimation using the investigational POROUS R4C ultrasound device.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male individuals aged 21 to and including 55 years.
- •Written informed consent has been obtained.
排除标准
- •Presence of diseases that rule out valid measurements with the DXA and POROUS R4C ultrasound devices (e.g., fractures or metal implants in the examined bones, paralysis of the lower extremities, severe bone abnormalities).
- •Open wounds or skin infections at the measurement site of the POROUS R4C ultrasound device.
- •Inability to undergo the investigations required by the Clinical Investigation Plan (CIP) or cognitive limitations that preclude understanding of the Participant Information Sheet and the Informed Consent Document.
- •Pregnancy and breastfeeding
- •Individual is in custody by order of an authority or a court of law.
- •Close affiliation with an investigational site, e.g., employment at an investigational site, close relative of an investigator, or dependent person (e.g., student of the investigational site).
研究组 & 干预措施
BMD estimation in young and middle-aged men and women
All participants are examined with the investigational device (POROUS R4C ultrasound device) and a comparator device (DXA).
干预措施: Measurements with the POROUS R4C ultrasound device at the midshaft tibia (Device)
BMD estimation in young and middle-aged men and women
All participants are examined with the investigational device (POROUS R4C ultrasound device) and a comparator device (DXA).
干预措施: DXA measurement of the hip and lumbar spine (Device)
结局指标
主要结局
Primary Clinical Endpoint - POROUS
时间窗: 12 months
Assessment of the POROUS R4C ultrasound device in estimating surrogate aBMD values (total femur). The primary endpoint aims to obtain a statistically significant correlation between the surrogate POROUS-aBMD values and the respective DXA-aBMD values (total femur). Outcome measure: POROUS-aBMD (g/cm\^2).
Primary Clinical Endpoint - DXA
时间窗: 12 months
Outcome measure: DXA-aBMD values - total femur (g/cm\^2)
次要结局
- Secondary Clinical Endpoint - DXA(12 months)
- Secondary Clinical Endpoint - POROUS(12 months)
- Safety Endpoint: Incidence of procedural/device-related adverse events(12 months)
- Secondary Clinical Endpoint - POROUS(12 months)
- Secondary Clinical Endpoint - DXA(12 months)