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

NCT06385938 | Withdrawn

• 1 other identifier: 23-012048
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rickets

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Relationship of ultrasound images with radiographic evidence of rickets

  Baseline

• Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects

  Baseline

• Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets

  Baseline

Study Arms (2)

Children with Active Rickets Group

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.

Diagnostic Test: Ultrasound with quantitative vibro-acoustic assessment

Healthy Children Control Group

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.

Diagnostic Test: Ultrasound with quantitative vibro-acoustic assessment

Interventions

Ultrasound with quantitative vibro-acoustic assessment DIAGNOSTIC_TEST

Imaging with non-invasive bone assessment based on wide range of frequencies and free from soft tissue artifact of the wrists and the knees

Children with Active Rickets Group; Healthy Children Control Group

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Known fracture at imaging site
• Rickets of prematurity

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Rickets

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Thomas D Thacher, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 26, 2024
• Study Start: March 13, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share