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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06385938
Enrollment
0
Registered
2024-04-26
Start date
2024-03-13
Completion date
2024-12-05
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rickets

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.

Interventions

DIAGNOSTIC_TESTUltrasound 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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Relationship of quantitative vibro-acoustic ultrasound and rickets severity scoreBaselineQuantitative 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

MeasureTime frameDescription
Relationship of ultrasound images with radiographic evidence of ricketsBaselineDetermine 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 subjectsBaseline2\. 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 ricketsBaselineTo 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026