Clinical trial NCT06385938: Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten
Official title: Ultrasound Imaging and Quantitative Vibro-acoustic Assessment of Rickets in Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rickets
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 0
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prepubertal children \<10 years of age at enrollment with active nutritional or genetic rickets recruited from the Mayo Clinic Pediatric Endocrinology Bone Clinic or from the Mayo Clinic outpatient or inpatient services in Rochester, MN (cases). Healthy matched control children will be recruited from children empaneled in Mayo Clinic primary care (Family Medicine or Community Pediatrics).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship of quantitative vibro-acoustic ultrasound and rickets severity score
timeFrame: Baseline
Secondary outcomes:
measure: Relationship of ultrasound images with radiographic evidence of rickets
timeFrame: Baseline
measure: Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects
timeFrame: Baseline
measure: Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Thomas D Thacher, MD
role: PRINCIPAL_INVESTIGATOR
References: