Opportunistic Fragility Fracture Risk Estimates From Radiographs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 497
- 试验地点
- 1
- 主要终点
- T-scores as calculated by IbexBH and DXA
研究概览
简要总结
The proposed study will predict a patients' risk of having osteoporosis by using a combination of the IBEX BH (Bone Health) software outputs and other clinical risk factors such as age, gender, medical history and lifestyle. A comparison will be made between the IBEX BH prediction and the one calculated in current clinical practice using a tool called FRAX (Fracture Risk Assessment Tool) which combines clinical risk factors with results from a Dual Energy X-ray Absorptiometry (DXA) assessment.
The study involves conducting these assessments on several new anatomies including Knee, Ankle and Pelvis, to extend the market reach and clinical utility of IBEX BH. The expected outcome of the study is that the IBEX BH will offer better decision support to clinicians in terms of referral on for a DXA scan or osteoporosis investigations than available today.
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
- 20 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •50 years of age or over
排除标准
- •Women who are pregnant or are breastfeeding.
- •Participants who have sustained fractures in both hips.
- •Unwilling or unable to provide informed consent.
- •For the collection of healthy-normal data in the study.
- •Inclusion Criteria:
- •Male or female
- •20-30 years of age
- •Exclusion Criteria:
- •Women who are pregnant or are breastfeeding.
- •Participants who have sustained fractures in both hips.
- •Unwilling or unable to provide informed consent.
结局指标
主要结局
T-scores as calculated by IbexBH and DXA
时间窗: 2 hours on 1 visit only
次要结局
- Estimated 10-year risk of major osteoporotic fracture as outputted by FRAX (with and without DXA aBMD (Areal Bone Mineral Density) and IbexBH)(2 hours on same visit as above)