Bone AgeNCT01346618
The Validity of Bone Age Assessment by an Ultrasound Apparatus (SonicBone)
An observational study of Bone Age, run by Assaf Harofeh MC at 1 site in Israel.
Trial summary
Bone age assessment is currently an important tool in final height implication in children. It is an important tool in the phases of investigation and treatment of short stature, tall stature, pubertal timing and various endocrinological pediatric situations. It is currently assessed using hand x-ray. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Age
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to Mar 2013
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants are children and youth ages 4-17 years (inclusive) who performed or will perform a X-ray of the left hand for bone age assessment as part of any clinical work up, within 2 months of enrollment in this study. Participants will be recruited according to advertising the study amongst pediatricians, pediatric endocrinologists and from the pediatric population who visits the pediatric endocrine clinic, endocrine testing room, adolescent medicine clinic, or being hospitalized at the pediatric division, Assaf Haroffeh Medical Center.
Who may be able to join
- Children aged 4-17 years old
- Children who performed or will perform a hand x-ray as part of their clinical work up within 2 months from study enrolment
- A signed Informed Consent Form that was obtained from at least one parent or legal guardian and an audio approval by the other (phone call), if available, prior to ultrasound study.
- An assent from the child to perform the SonicBone's BA device reading
Who cannot join
- Children taking any medication that might change bone metabolism or mineralization within the last year (glucocorticosteroids, sex steroids, oral contraceptives, anticonvulsants, calcium and vitamin D in superphysiological doses)
- Children with suspected bone diseases or multiple fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Bone Age Assessment by an Ultrasound Apparatus (SonicBone) and the X-ray Based Grulich and Pyle Method
Bone age assessment is currently an important tool in final height implication in children. It is an important tool in the phases of investigation and treatment of short stature, tall stature, pubertal timing and various endocrinological pediatric situations. It is currently assessed using hand x-ray. This method has several limitations, including: requirement of specialized medical staff to interpret results, exposure radiation and usage of equipment which is only in radiology centers. The investigators aim to study a new equipment, radiation free, with simple and swift operation which provides an immediate answer, no need for an experienced observer, a mobile equipment with easy accessibility. The aim of the study is to assess its reproducibility, validity and safety compared to the x-ray method.
The investigators hypothesize it is as accurate and valid.
Read the detailed description
Skeletal maturity assessment, defined also as bone age (BA), has an important role in pediatrics and pediatric endocrinology, used mainly for evaluating growth and puberty related endocrine disorders. Repeated BA assessment is important during the follow up of children with short stature, with precocious puberty and those treated by growth promoting medications.
The most commonly used method used for determining skeletal maturity, and thus BA is based on comparison of a hand and wrist radiographs to a standard series of representative films in the "Radiographic atlas of skeletal development of the hand and wrist" by Greulich and Pyle (GP), which has been issued several decades ago. Among the disadvantages and drawbacks in this BA assessment method are: the obligatory need for using radiology units that are often available only in special facilities or hospitals, not available at the physicians office, the exposure to ionizing radiation, and the known limitation of the method for the need of an endocrinologist to assess the BA, with a known large inter observers variability of the BA interpretation.
The suggested method in this study is based on ultrasound technology, and therefore it is quick, objective, and radiation-free. It delivers an immediate non biased result without the need to rely on an observer's evaluation of the hand radiograph and without the need for a specialized radiology facility.
This technique was innovated in order to find an efficient, convenient and non radiation based method of skeletal maturity assessment for the primary care physician that can be performed in an office setting.
The aim of this study is to establish a correlation algorithm between the BA assessment by an ultrasound apparatus (SonicBone) and the X-ray based assessment using Grulich and Pyle method, and to evaluate the validity and reproducibility of the apparatus, The design of the study is to perform a concomitant skeletal maturation assessment by reading of a hand X-ray radiograph by 3 experienced observers using the GP method, and by the ultrasound technique using the SonicBone apparatus. Skeletal maturation assessment will be performed in females and males at various age groups.
- Conditions
- Bone Age
- Keywords
- bone age, children, x-ray, ultrasound, ultrasound based method, safe, valid, reproducable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children ages 4-17 years | Participants are children and youth ages 4-17 years (inclusive) who performed or will perform a X-ray of the left hand for bone age assessment as part of any clinical work up, within 2 months of enrollment in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BA assessment readings by the SonicBone's BA device compared to the traditional GP method based reading of left hand x-ray and their reproducibility
Measured: 9 months
Secondary outcomes (1)
The number of participants experiencing adverse side affects
Symptoms of pain, local erythema, syncope or pruritis will be assessed. Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AgeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf Harofeh MC
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Marianna Rachmiel, MD, Principal investigator, Assaf Haroffeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346618
- Sponsor's protocol ID
- 11/11
- Status last verified
- Dec 2022
- First submitted
- 25 Apr 2011
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Bone Age Assessment by an Ultrasound Apparatus (SonicBone) and the X-ray Based Grulich and Pyle Method
- ClinicalTrials.gov ID
- NCT01346618
- Acronym / sponsor ID
- 11/11
- Conditions
- Bone Age
- Keywords
- bone age, children, x-ray, ultrasound, ultrasound based method, safe, valid, reproducable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assaf Harofeh MCOther government
- Study start
- May 2011 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 May 2011 (estimated)
- 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.
Bone age assessment is currently an important tool in final height implication in children. It is an important tool in the phases of investigation and treatment of short stature, tall stature, pubertal timing and various endocrinological pediatric situations. It is currently assessed using hand x-ray. This method has several limitations, including: requirement of specialized medical staff to interpret results, exposure radiation and usage of equipment which is only in radiology centers. The investigators aim to study a new equipment, radiation free, with simple and swift operation which provides an immediate answer, no need for an experienced observer, a mobile equipment with easy accessibility. The aim of the study is to assess its reproducibility, validity and safety compared to the x-ray method.
The investigators hypothesize it is as accurate and valid.
Detailed description
Skeletal maturity assessment, defined also as bone age (BA), has an important role in pediatrics and pediatric endocrinology, used mainly for evaluating growth and puberty related endocrine disorders. Repeated BA assessment is important during the follow up of children with short stature, with precocious puberty and those treated by growth promoting medications.
The most commonly used method used for determining skeletal maturity, and thus BA is based on comparison of a hand and wrist radiographs to a standard series of representative films in the "Radiographic atlas of skeletal development of the hand and wrist" by Greulich and Pyle (GP), which has been issued several decades ago. Among the disadvantages and drawbacks in this BA assessment method are: the obligatory need for using radiology units that are often available only in special facilities or hospitals, not available at the physicians office, the exposure to ionizing radiation, and the known limitation of the method for the need of an endocrinologist to assess the BA, with a known large inter observers variability of the BA interpretation.
The suggested method in this study is based on ultrasound technology, and therefore it is quick, objective, and radiation-free. It delivers an immediate non biased result without the need to rely on an observer's evaluation of the hand radiograph and without the need for a specialized radiology facility.
This technique was innovated in order to find an efficient, convenient and non radiation based method of skeletal maturity assessment for the primary care physician that can be performed in an office setting.
The aim of this study is to establish a correlation algorithm between the BA assessment by an ultrasound apparatus (SonicBone) and the X-ray based assessment using Grulich and Pyle method, and to evaluate the validity and reproducibility of the apparatus, The design of the study is to perform a concomitant skeletal maturation assessment by reading of a hand X-ray radiograph by 3 experienced observers using the GP method, and by the ultrasound technique using the SonicBone apparatus. Skeletal maturation assessment will be performed in females and males at various age groups.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children ages 4-17 years | – | –Participants are children and youth ages 4-17 years (inclusive) who performed or will perform a X-ray of the left hand for bone age assessment as part of any clinical work up, within 2 months of enrollment in this study. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants are children and youth ages 4-17 years (inclusive) who performed or will perform a X-ray of the left hand for bone age assessment as part of any clinical work up, within 2 months of enrollment in this study. Participants will be recruited according to advertising the study amongst pediatricians, pediatric endocrinologists and from the pediatric population who visits the pediatric endocrine clinic, endocrine testing room, adolescent medicine clinic, or being hospitalized at the pediatric division, Assaf Haroffeh Medical Center.
Key inclusion criteria (4 listed)
- Children aged 4-17 years old
- Children who performed or will perform a hand x-ray as part of their clinical work up within 2 months from study enrolment
- A signed Informed Consent Form that was obtained from at least one parent or legal guardian and an audio approval by the other (phone call), if available, prior to ultrasound study.
- An assent from the child to perform the SonicBone's BA device reading
Key exclusion criteria (2 listed)
- Children taking any medication that might change bone metabolism or mineralization within the last year (glucocorticosteroids, sex steroids, oral contraceptives, anticonvulsants, calcium and vitamin D in superphysiological doses)
- Children with suspected bone diseases or multiple fractures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BA assessment readings by the SonicBone's BA device compared to the traditional GP method based reading of left hand x-ray and their reproducibility
Time frame: 9 months
1 secondary outcome
The number of participants experiencing adverse side affects
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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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.
Marianna Rachmiel, MD principal investigator
Assaf Haroffeh Medical Center
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 Bone Age, run by Assaf Harofeh MC at 1 site in Israel.
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 4 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: finished, as of the sponsor's last update on 6 Dec 2022. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BA assessment readings by the SonicBone's BA device compared to the traditional GP method based reading of left hand x-ray and their reproducibility (time frame: 9 months). 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 6 Dec 2022.