NCT06385938撤回不适用
Ultrasound Imaging and Quantitative Vibro-acoustic Assessment of Rickets in Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 主要终点
- Relationship of quantitative vibro-acoustic ultrasound and rickets severity score
研究概览
简要总结
The goal of this study is to find out if the use of ultrasound pictures of bones can spot changes in the growth areas of children with rickets, a condition that affects how bones harden. Researchers want to see if these ultrasound pictures can help tell the difference between children who have rickets and those who don't.
详细描述
Aims, purpose, or objectives:
- To determine if ultrasound imaging of bone can identify the changes of impaired mineralization of the growth plates at the wrists and the knees, similar to those visible on plain radiographs.
- To determine if quantitative vibro-acoustic measurements of the bone in subjects with rickets significantly differs from control subjects, matched for age, sex, and BMI.
- To determine the relationship of ultrasound images and quantitative vibro-acoustic assessment with rickets severity score (RSS), based on radiographs of the wrists and knees.
- To determine if longitudinal changes in ultrasound images and quantitative vibro-acoustic assessment with treatment of rickets are related to changes in the rickets severity score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases: Prepubertal children less than 10 years of age with active nutritional or genetic rickets at enrollment (RSS>1.5 based on radiographs of the wrists and knees performed within 3 months prior to enrollment). Cases will be recruited from the Pediatric Endocrinology Bone Clinic or from the Mayo Clinic outpatient or inpatient services in Rochester, MN. Cases who return for follow-up and demonstrate improvement in RSS≥1.0 will be eligible for a single repeat ultrasound evaluation.
- •Controls: Healthy children empaneled in Mayo Clinic primary care (Family Medicine or Community Pediatrics) matched for age (±3 months), sex, and BMI (±0.5 kg/m2)
排除标准
- •Known fracture at imaging site
- •Rickets of prematurity
结局指标
主要结局
Relationship of quantitative vibro-acoustic ultrasound and rickets severity score
时间窗: Baseline
Quantitative vibro-acoustic data will be compared with the radiographic rickets severity score to assess if ultrasound measures are reliably related to the radiographic findings.
次要结局
- Relationship of ultrasound images with radiographic evidence of rickets(Baseline)
- Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects(Baseline)
- Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets(Baseline)
研究者
Thomas Thacher
Principal Investigator
Mayo Clinic
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