Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten
- Conditions
- Rickets
- Interventions
- Diagnostic Test: Ultrasound with quantitative vibro-acoustic assessment
- Registration Number
- NCT06385938
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Aims, purpose, or objectives:
1. 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.
2. 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.
3. 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.
4. 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 45
- 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)
- Known fracture at imaging site
- Rickets of prematurity
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children with Active Rickets Group Ultrasound with quantitative vibro-acoustic assessment Children under 10 years of age with a diagnosis of active rickets on radiographs of the wrists and knees will undergo ultrasound imaging and quantitative vibro-acoustic assessment. Healthy Children Control Group Ultrasound with quantitative vibro-acoustic assessment Healthy children under 10 years of age not diagnosed with rickets, but match the age, gender, and weight of the children with rickets, will undergo ultrasound imaging and quantitative vibro-acoustic assessment.
- Primary Outcome Measures
Name Time Method Relationship of quantitative vibro-acoustic ultrasound and rickets severity score 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.
- Secondary Outcome Measures
Name Time Method Relationship of ultrasound images with radiographic evidence of rickets Baseline 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
Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects Baseline 2. 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.
Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets Baseline 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
Trial Locations
- Locations (1)
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States