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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06385938
Other study ID # 23-012048
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date April 2026

Study information

Verified date June 2024
Source Mayo Clinic
Contact Mary A Johnson
Phone 507-422-6823
Email johnson.mary15@mayo.edu
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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