Adolescent Idiopathic ScoliosisEARLYBIRDNCT05924347
Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development
An observational study of Adolescent Idiopathic Scoliosis and 22q11.2 Deletion Syndrome, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Rationale: Despite several decades of research, the exact etiology of adolescent idiopathic scoliosis (AIS) remains unclear. In AIS, spine curvature begins with and progresses during the adolescent growth spurt. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, 22q11.2 Deletion Syndrome
- What is being tested?
- MRI, Scolioscan and Skeletal maturity assessment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Jun 2023to 1 May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Cohort 1: 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) Cohort 2: 60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development.
Who may be able to join
- Cohort 1:
- Female,
- 8, 9 or 10 years old
- An older sibling, twin or parent diagnosed with AIS
- Cohort 2:
- Diagnosed with 22q11.2DS
Show all 11Show fewer
- Girls: 8, 9 or 10 years old.
- Boys: 9, 10 or 11 years old.
- All
- No clinical signs of scoliosis at inclusion (physical examination by forward bending test and Bunnell Scoliometer assessment with a cut-off value of 7°.
- Written informed consent of parents/legal representatives.
Who cannot join
- Contraindications for MR imaging
- Early-onset scoliosis or other spinal deformities
- Other syndromes or neuromuscular disease associated with scoliosis
- Clinical signs of >1cm leg length discrepancy
- Other diseases or injuries, that are related to abnormal spinal growth, posture, activity levels, or scoliosis development.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hilde Stempels contact
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, 3584 CX
Tom Schlösser, MD, PhD, t.p.c.schlosser@umcutrecht.nl
About this study
Official title: Longitudinal MRI Study to Catch EARLY Scoliotic Changes of the Bone and Intervertebral Disc in Younger Sisters and Daughters of Adolescent Idiopathic Scoliosis Patients and the 22q11.2DS Population.
Rationale: Despite several decades of research, the exact etiology of adolescent idiopathic scoliosis (AIS) remains unclear. In AIS, spine curvature begins with and progresses during the adolescent growth spurt. Previous studies are only performed on populations with already established scoliosis and normal spinal growth (of bone and IVD tissue) during adolescence has also not been defined. Growth pattern differences may exist between scoliotic and nonscoliotic subjects. Previous studies support the hypothesis that AIS is a spinal deformity that starts with decompensation in the IVD and is linked to sagittal spinal alignment. However, to understand its cause and pathogenic mechanism, the changes to the adolescent spine must be assessed longitudinally during the growth period coinciding with the period prior to and during the onset of AIS. Ideally this should include a cohort who do and do not develop AIS and their assessment must be minimally harmful, without radiation exposure. Certain populations are at increased risk for scoliosis development (i.e. girls with family members with scoliosis and 22q11.2DS patients). New imaging modalities (boneMRI, 3D spinal ultrasound) allow for non-radiographic monitoring of spinal growth.
Read the detailed description
Objective: The primary objectives is: To longitudinally evaluate the substantial differences in anatomical changes in the spine during adolescent growth in girls, at increased risk for scoliosis development, and in adolescent 22q11.2DS patients, that do and do not develop AIS.
The secondary objectives are:
- To develop spine specific (IVD/endplates) maturity assessment grading.
- To implement radiation-free imaging methods for spinal monitoring in adolescent patients at risk for scoliosis development.
- To create a longitudinal dataset for patient specific spinal biomechanical assessment.
Study design: Prospective observational cohort study
Study population: 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) (Cohort-1) and 60 adolescent girls and boys with 22q11.2DS with increased risk for idiopathic-like scoliosis development (Cohort-2).
Intervention: none
Main study parameters/endpoints: Spinal MR imaging of the thoracic and lumbar spine will be performed at 5 time points between 8 or 9 and 15 or 16 for girls and boys respectively to evaluate possible changes in the 3D anatomy of the spine. The main study parameter will be the longitudinal changes in segmental axial rotation on boneMRI of the thoracolumbar spine in subjects that do and do not develop AIS.
Secondary endpoints: Changes in bone and intervertebral disc morphology, lateral shift of the nucleus pulposus. These will be correlated to assessments of growth, skeletal maturity and spinal alignment.
- Being tested
- MRI, Scolioscan, Skeletal maturity assessment
- Medical subject headings
- DiGeorge Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Longitudinal MRI examination of the thoracic and lumbar spine (T2, T2w, sCT)
ScolioscanDiagnostic test
3D ultrasound of the spine
Skeletal maturity assessmentDiagnostic test
At one timepoint, a Hand radiograph is taken for digital skeletal maturity assessment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) Receives: Diagnostic Test: MRI; Diagnostic Test: Scolioscan; Diagnostic Test: Skeletal maturity assessment | |
| Cohort 2 | 60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development. Receives: Diagnostic Test: MRI; Diagnostic Test: Scolioscan; Diagnostic Test: Skeletal maturity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Girls: Baseline
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Girls: 11year
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Girls: 12year
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Girls: 13year
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Girls: 15year
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Boys: Baseline
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Boys: 12year
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Boys: 13year
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Boys: 14year
Spinal MR Imaging of the thoracic and lumbar spine
MRI images
Measured: Boys: 16year
Secondary outcomes (62)
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Girls: Baseline
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Girls: 11year
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Girls: 12year
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Girls: 13year
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Girls: 15year
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Boys: Baseline
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Boys: 12year
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Boys: 13year
A-P ratio vertebrae and disc
Ratio anterior and posterior height
Measured: Boys: 14year
A-P ratio vertebrae
Ratio anterior and posterior height
Measured: Boys: 16year
Left-right ratio
Ratio left and right height
Measured: Girls: Baseline
Left-right ratio
Ratio left and right height
Measured: Girls: 11year
Left-right ratio
Ratio left and right height
Measured: Girls: 12year
Left-right ratio
Ratio left and right height
Measured: Girls: 13year
Left-right ratio
Ratio left and right height
Measured: Girls: 15year
Left-right ratio
Ratio left and right height
Measured: Boys: Baseline
Left-right ratio
Ratio left and right height
Measured: Boys: 12year
Left-right ratio
Ratio left and right height
Measured: Boys: 13year
Left-right ratio
Ratio left and right height
Measured: Boys: 14year
Left-right ratio
Ratio left and right height
Measured: Boys: 16year
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Girls: Baseline
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Girls: 11year
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Girls: 12year
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Girls: 13year
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Girls: 15year
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Boys: Baseline
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Boys: 12year
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Boys: 13year
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Boys: 14year
Torsion
Difference in axial rotation between 2 subsequent endplates
Measured: Boys: 16year
Volumes disc
Volumes disc
Measured: Girls: Baseline
Volumes disc
Volumes disc
Measured: Girls: 11year
Volumes disc
Volumes disc
Measured: Girls: 12year
Volumes disc
Volumes disc
Measured: Girls: 13year
Volumes disc
Volumes disc
Measured: Girls: 15year
Volumes disc
Volumes disc
Measured: Boys: Baseline
Volumes disc
Volumes disc
Measured: Boys: 12year
Volumes disc
Volumes disc
Measured: Boys: 13year
Volumes disc
Volumes disc
Measured: Boys: 14year
Volumes disc
Volumes disc
Measured: Boys: 16year
Volumes vertebrae
Volumes vertebrae
Measured: Girls: Baseline
Volumes vertebrae
Volumes vertebrae
Measured: Girls: 11year
Volumes vertebrae
Volumes vertebrae
Measured: Girls: 12year
Volumes vertebrae
Volumes vertebrae
Measured: Girls: 13year
Volumes vertebrae
Volumes vertebrae
Measured: Girls: 15year
Volumes vertebrae
Volumes vertebrae
Measured: Boys: Baseline
Volumes vertebrae
Volumes vertebrae
Measured: Boys: 12year
Volumes vertebrae
Volumes vertebrae
Measured: Boys: 13year
Volumes vertebrae
Volumes vertebrae
Measured: Boys: 14year
Volumes vertebrae
Volumes vertebrae
Measured: Boys: 16year
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Girls: Baseline
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Girls: 11year
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Girls: 12year
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Girls: 13year
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Girls: 15year
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Boys: Baseline
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Boys: 12year
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Boys: 13year
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Boys: 14y
Shift nucleus pulposis
Position of nucleus pulposus in discus
Measured: Boys: 16year
Changes in spinal alignment during growth
Scan for changes over growth
Measured: Girls: Baseline-15years, Boys: Baseline-15years
Spine specific maturity assessment grading
See if it is possible to create a spine specific maturity assessment
Measured: Girls: Baseline-15years, Boys: Baseline-15years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start16 Jun 2023
- Primary completionMay 2032 (estimated)
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology
- Responsible party
- Principal investigator, dr. Tom P.C. Schlösser, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924347
- Sponsor's protocol ID
- NL82419.041.22
- Acronym
- EARLYBIRD
- Status last verified
- Jun 2023
- First submitted
- 26 Jan 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lafranca PPG, Stempels HW, de Reuver S, Houben ML, Kok J, Kruyt MC, Castelein RM, Seevinck PR, van der Velden T, Shcherbakova YM, Ito K, Schlosser TPC. EARLYBIRD: catching the earliest changes of the bone and intervertebral discs in children at increased risk for scoliosis development with MRI - study protocol of a prospective observational cohort study. BMJ Open. 2025 Jun 26;15(6):e098929. doi: 10.1136/bmjopen-2025-098929.
PubMed 40578865
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal MRI Study to Catch EARLY Scoliotic Changes of the Bone and Intervertebral Disc in Younger Sisters and Daughters of Adolescent Idiopathic Scoliosis Patients and the 22q11.2DS Population.
- ClinicalTrials.gov ID
- NCT05924347
- Acronym / sponsor ID
- EARLYBIRD / NL82419.041.22
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- May 2032 (estimated)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 29 Jun 2023 (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.
Rationale: Despite several decades of research, the exact etiology of adolescent idiopathic scoliosis (AIS) remains unclear. In AIS, spine curvature begins with and progresses during the adolescent growth spurt. Previous studies are only performed on populations with already established scoliosis and normal spinal growth (of bone and IVD tissue) during adolescence has also not been defined. Growth pattern differences may exist between scoliotic and nonscoliotic subjects. Previous studies support the hypothesis that AIS is a spinal deformity that starts with decompensation in the IVD and is linked to sagittal spinal alignment. However, to understand its cause and pathogenic mechanism, the changes to the adolescent spine must be assessed longitudinally during the growth period coinciding with the period prior to and during the onset of AIS. Ideally this should include a cohort who do and do not develop AIS and their assessment must be minimally harmful, without radiation exposure. Certain populations are at increased risk for scoliosis development (i.e. girls with family members with scoliosis and 22q11.2DS patients). New imaging modalities (boneMRI, 3D spinal ultrasound) allow for non-radiographic monitoring of spinal growth.
Detailed description
Objective: The primary objectives is: To longitudinally evaluate the substantial differences in anatomical changes in the spine during adolescent growth in girls, at increased risk for scoliosis development, and in adolescent 22q11.2DS patients, that do and do not develop AIS.
The secondary objectives are:
- To develop spine specific (IVD/endplates) maturity assessment grading.
- To implement radiation-free imaging methods for spinal monitoring in adolescent patients at risk for scoliosis development.
- To create a longitudinal dataset for patient specific spinal biomechanical assessment.
Study design: Prospective observational cohort study
Study population: 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) (Cohort-1) and 60 adolescent girls and boys with 22q11.2DS with increased risk for idiopathic-like scoliosis development (Cohort-2).
Intervention: none
Main study parameters/endpoints: Spinal MR imaging of the thoracic and lumbar spine will be performed at 5 time points between 8 or 9 and 15 or 16 for girls and boys respectively to evaluate possible changes in the 3D anatomy of the spine. The main study parameter will be the longitudinal changes in segmental axial rotation on boneMRI of the thoracolumbar spine in subjects that do and do not develop AIS.
Secondary endpoints: Changes in bone and intervertebral disc morphology, lateral shift of the nucleus pulposus. These will be correlated to assessments of growth, skeletal maturity and spinal alignment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: MRI, Diagnostic Test: Scolioscan, Diagnostic Test: Skeletal maturity assessment60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) |
| Cohort 2 | – | Diagnostic Test: MRI, Diagnostic Test: Scolioscan, Diagnostic Test: Skeletal maturity assessment60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cohort 1: 60 adolescent girls (8-10 years old) at increased risk for idiopathic scoliosis development (an older sibling or parent diagnosed with idiopathic scoliosis) Cohort 2: 60 adolescent girls or boys with the 22q11.2DS with increased risk for idiopathic-like scoliosis development.
Key inclusion criteria (11 listed)
- Female,
- 8, 9 or 10 years old
- An older sibling, twin or parent diagnosed with AIS
- Diagnosed with 22q11.2DS
- Girls: 8, 9 or 10 years old.
Key exclusion criteria (5 listed)
- Contraindications for MR imaging
- Early-onset scoliosis or other spinal deformities
- Other syndromes or neuromuscular disease associated with scoliosis
- Clinical signs of >1cm leg length discrepancy
- Other diseases or injuries, that are related to abnormal spinal growth, posture, activity levels, or scoliosis development.
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 |
|---|---|---|
| MRILongitudinal MRI examination of the thoracic and lumbar spine (T2, T2w, sCT) | Diagnostic test | Cohort 1, Cohort 2 |
| Scolioscan3D ultrasound of the spine | Diagnostic test | Cohort 1, Cohort 2 |
| Skeletal maturity assessmentAt one timepoint, a Hand radiograph is taken for digital skeletal maturity assessment | Diagnostic test | Cohort 1, Cohort 2 |
Primary outcome
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Girls: Baseline
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Girls: 11year
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Girls: 12year
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Girls: 13year
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Girls: 15year
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Boys: Baseline
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Boys: 12year
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Boys: 13year
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Boys: 14year
MRI images
Spinal MR Imaging of the thoracic and lumbar spine
Time frame: Boys: 16year
MRI images
62 secondary outcomes
A-P ratio vertebrae and disc
Time frame: Girls: Baseline
A-P ratio vertebrae and disc
Time frame: Girls: 11year
A-P ratio vertebrae and disc
Time frame: Girls: 12year
A-P ratio vertebrae and disc
Time frame: Girls: 13year
A-P ratio vertebrae and disc
Time frame: Girls: 15year
A-P ratio vertebrae and disc
Time frame: Boys: Baseline
A-P ratio vertebrae and disc
Time frame: Boys: 12year
A-P ratio vertebrae and disc
Time frame: Boys: 13year
A-P ratio vertebrae and disc
Time frame: Boys: 14year
A-P ratio vertebrae
Time frame: Boys: 16year
Left-right ratio
Time frame: Girls: Baseline
Left-right ratio
Time frame: Girls: 11year
Left-right ratio
Time frame: Girls: 12year
Left-right ratio
Time frame: Girls: 13year
Left-right ratio
Time frame: Girls: 15year
Left-right ratio
Time frame: Boys: Baseline
Left-right ratio
Time frame: Boys: 12year
Left-right ratio
Time frame: Boys: 13year
Left-right ratio
Time frame: Boys: 14year
Left-right ratio
Time frame: Boys: 16year
Torsion
Time frame: Girls: Baseline
Torsion
Time frame: Girls: 11year
Torsion
Time frame: Girls: 12year
Torsion
Time frame: Girls: 13year
Torsion
Time frame: Girls: 15year
Torsion
Time frame: Boys: Baseline
Torsion
Time frame: Boys: 12year
Torsion
Time frame: Boys: 13year
Torsion
Time frame: Boys: 14year
Torsion
Time frame: Boys: 16year
Volumes disc
Time frame: Girls: Baseline
Volumes disc
Time frame: Girls: 11year
Volumes disc
Time frame: Girls: 12year
Volumes disc
Time frame: Girls: 13year
Volumes disc
Time frame: Girls: 15year
Volumes disc
Time frame: Boys: Baseline
Volumes disc
Time frame: Boys: 12year
Volumes disc
Time frame: Boys: 13year
Volumes disc
Time frame: Boys: 14year
Volumes disc
Time frame: Boys: 16year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 40578865Lafranca PPG, Stempels HW, de Reuver S, Houben ML, Kok J, Kruyt MC, Castelein RM, Seevinck PR, van der Velden T, Shcherbakova YM, Ito K, Schlosser TPC. EARLYBIRD: catching the earliest changes of the bone and intervertebral discs in children at increased risk for scoliosis development with MRI - study protocol of a prospective observational cohort study. BMJ Open. 2025 Jun 26;15(6):e098929. doi: 10.1136/bmjopen-2025-098929.
- Individual participant dataSharing planned: Yes
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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.
Hilde Stempels contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis and 22q11.2 Deletion Syndrome, run by UMC Utrecht at 1 site in Netherlands.
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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Schlosser (+31 88 75 53602, t.p.c.schlosser@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal MR Imaging of the thoracic and lumbar spine (time frame: Girls: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05924347, which also lists 1 linked publication.
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 29 Jun 2023.