RicketsNCT06385938
Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten
An observational study of Rickets, run by Mayo Clinic.
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. Read more about this study
- Who is it for?
- Ages Up to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Rickets
- What is being tested?
- Ultrasound with quantitative vibro-acoustic assessment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Mar 2024to 5 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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)
Who cannot join
- Known fracture at imaging site
- Rickets of prematurity
About this study
Official title: Ultrasound Imaging and Quantitative Vibro-acoustic Assessment of Rickets in Children
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:
- 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.
- 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.
- 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.
- 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.
- Conditions
- Rickets
- Being tested
- Ultrasound with quantitative vibro-acoustic assessment
- Medical subject headings
- Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound with quantitative vibro-acoustic assessmentDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Ultrasound with quantitative vibro-acoustic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
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
Measured: Baseline
Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects
- 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.
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start13 Mar 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RicketsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Thacher, Mayo Clinic
- Investigators
- Thomas D Thacher, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385938
- Sponsor's protocol ID
- 23-012048
- Status last verified
- Dec 2024
- First submitted
- 18 Apr 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging and Quantitative Vibro-acoustic Assessment of Rickets in Children
- ClinicalTrials.gov ID
- NCT06385938
- Acronym / sponsor ID
- 23-012048
- Conditions
- Rickets
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Active Rickets Group | – | Diagnostic Test: Ultrasound with quantitative vibro-acoustic assessmentChildren 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. |
| Healthy Children Control Group | – | Diagnostic Test: Ultrasound with quantitative vibro-acoustic assessmentHealthy 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. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Known fracture at imaging site
- Rickets of prematurity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound with quantitative vibro-acoustic assessmentImaging with non-invasive bone assessment based on wide range of frequencies and free from soft tissue artifact of the wrists and the knees | Diagnostic test | Children with Active Rickets Group, Healthy Children Control Group |
Primary outcome
Relationship of quantitative vibro-acoustic ultrasound and rickets severity score
Time frame: Baseline
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.
3 secondary outcomes
Relationship of ultrasound images with radiographic evidence of rickets
Time frame: Baseline
Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects
Time frame: Baseline
Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas D Thacher, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Rickets, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship of quantitative vibro-acoustic ultrasound and rickets severity score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.