Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten

Rickets Clinical Trial

Official title:

Ultrasound Imaging and Quantitative Vibro-acoustic Assessment of Rickets in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06385938
• Other study ID #: 23-012048
• Status: Recruiting
• Start date: May 2024
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Mary A Johnson
• Phone: 507-422-6823
• Email: johnson.mary15[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Known fracture at imaging site
• Rickets of prematurity

Related Conditions & MeSH terms

• Rickets

Intervention

Diagnostic Test:
• Ultrasound with quantitative vibro-acoustic assessment
Imaging with non-invasive bone assessment based on wide range of frequencies and free from soft tissue artifact of the wrists and the knees

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of quantitative vibro-acoustic ultrasound and rickets severity score	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.	Baseline
Secondary	Relationship of ultrasound images with radiographic evidence of rickets	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	Baseline
Secondary	Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects	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.	Baseline
Secondary	Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets	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	Baseline