NCT07421713招募中不适用
A Retrospective Multi-centre Paired Accuracy Study to Evaluate the Performance of Osteo Signal Against the Dual-energy X-ray Absorptiometry (DXA) for Opportunistic Osteoporosis Screening.
Promedius Inc3 个研究点 分布在 2 个国家目标入组 595 人开始时间: 2026年2月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 595
- 试验地点
- 3
- 主要终点
- Two class bone status classification (osteoporosis/non osteoporosis)
研究概览
简要总结
The goal of this study is to assess the performance of an artificial intelligence software (Osteo Signal) in detecting osteoporosis risk in adults 50 years and older. The main question it aims to answer is: What is the accuracy of the software in detecting osteoporosis risk on chest x-ray images as compared to the standard technique of dual-energy x-ray absorptiometry (DXA)? There is no direct involvement of participants in this study as it will use data from individuals who have already had a chest x-ray and a DXA scan taken in the past.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥50 years at the time of chest X-ray
- •Availability of
- •Posteroanterior (PA) Chest X-ray and
- •DXA scan with a valid T-score measurement where both the DXA scan and Chest x-ray examinations were performed within 6 months (182 days) of each other and
- •Available X-ray and DXA scans performed on or after 01-Jan-
- •Complete metadata (sex and age) available on PACS or hospital records.
排除标准
- •Non-diagnostic Quality or Incomplete Imaging of:
- •DXA scan inadequacy: Missing T-score from a technically inadequate scan.
- •PA Chest X-ray technical inadequacy: Non-PA projection, significant motion artefacts, inadequate visualisation of thoracic structures, or missing DICOM metadata.
- •Image format incompatibility: Non-DICOM format or corrupted image files that would prevent AI analysis
- •PA Chest X-ray > ±6 months from the date of the DXA scan.
- •Previous diagnosis or treatment of Osteoporosis prior to the DXA scan used in the Study.
- •diagnosis of osteoporosis (T-score ≤-2.5), or current/recent anti- osteoporotic medications, within 12 months prior to the DXA scan used in the study.
- •Current or recent anti-osteoporotic medications for 3 months (91 days) continuously prior to the Chest x-ray used in the Study.
- •Diagnosis of any metabolic bone disease prior to the DXA scan used in the study.
- •Diagnosis of metabolic bone disease other than Osteoporosis or Osteopenia, up to a maximum of 3 months (91 days) after the DXA scan.
- •Major Chest Wall or Spinal Deformities, including but not limited to:
- •Severe structural deformities: Thoracic scoliosis with Cobb angle >40°, severe kyphosis, or chest wall deformities (pectus excavatum/carinatum) affecting >30% of the thoracic cage.
- •Surgical hardware: Previous thoracic/spinal surgery with metallic implants obscuring anatomical landmarks required for AI analysis.
- •Pathological conditions: Extensive pulmonary consolidation, pleural effusion, lesions or masses obscuring >30% of thoracic skeletal structures
- •Subject has opted out of confidential data being used for research purposes
结局指标
主要结局
Two class bone status classification (osteoporosis/non osteoporosis)
时间窗: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
Device output against the lowest DXA as measured by sensitivity, specificity, and area under the ROC curve (AUC)
次要结局
- Three class bone status classification (osteoporosis/osteopenia/normal)(At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other)
- Classification for osteoporosis and osteopenia(At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other)
研究者
研究点 (3)
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