ClinicalTrials.gg
WithdrawnNCT06385938Updated Dec 16, 2024

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

An observational study in Rickets, sponsored by Mayo Clinic. Withdrawn. Open to participants aged Up to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by Mayo Clinic · Observational

Why this study was withdrawn
Lack of enrollment
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
0
Ages
Up to 10 Years
Sex
All
01

Study 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.

Read the 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.
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Conditions studied

  • Rickets

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03

In context

Rickets

36 studies on the registry are indexed under Rickets; 2 are open to participants now.

Browse Rickets studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (±0.5 kg/m2)

Exclusion criteria

Exclusion Criteria:

  • Known fracture at imaging site
  • Rickets of prematurity
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

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What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. 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

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2024 to primary completion in Dec 2024, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 18, 2024
First posted
Apr 26, 2024
StartActual
Mar 13, 2024
Primary completionActual
Dec 5, 2024
CompletionActual
Dec 5, 2024
Last update
Dec 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06385938
Lead sponsor
Mayo Clinic
Responsible party
Thomas Thacher (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Apr 26, 2024
Start date
Mar 13, 2024
Primary completion
Dec 5, 2024
Completion
Dec 5, 2024
Last update
Dec 16, 2024

Study contacts

Thomas D Thacher, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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