Evaluation of Bone Age by Ultrasound TechnologyNCT01980693
Ultrasound Evaluation of Bone Age in Healthy Children
A study testing SonicBone ultrasound in people with Evaluation of Bone Age by Ultrasound Technology, run by Clalit Health Services at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Bone Age by Ultrasound Technology
- What is being tested?
- SonicBone ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Children aged 4-17 years old Children with normal (3%-97%) height values for their age Children with normal (3%-97%) weight values for their age Children with normal (5%-85%) BMI value for their age Children of Caucasian ethnical origin A signed Informed Consent Form that was obtained from at least one parent or legal guardian, prior to ultrasound study.
- An assent from the child to perform the SonicBone's BA device measurement
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, metabolic diseases, chronic diseases or multiple fractures.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pediatric Community Ambulatory Clinic
Petah Tikva
Cohen Herman, MD, 972-3-9398203, hermanc@post.tau.ac.il
Cohen Herman, MD
About this study
Official title: Cohort Study to Investigate the Relationship Between Ultrasound Apparatus Results (SonicBone's BAUS) and Skeletal Maturity Status (Bone Age) Among Healthy Children and Adolescence
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. 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.
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 new bone age database by an ultrasound apparatus (SonicBone) that will eventually replace the X-ray based assessment using Greulich and Pyle and Tanner \& Whitehouse Atlas and methods.
The design of the study is to perform a concomitant skeletal maturation assessment by reading of an ultrasound technique using the SonicBone apparatus. Skeletal maturation assessment will be performed in females and males at various age groups from 4-17 years old.
- Being tested
- SonicBone ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonicBone ultrasoundDevice
Also called SonicBone BA, SonicBone Medical
The device measure BA using ultrasound technology by measurement of speed of sound in three different sites : wrist bones, Phalanx III, Metacarpal bones.The device sends a short US pulse and measures the distance between a transmitter probe and a receiver probe, located at the bone measured area.The US probe converts electrical pulse to US pulse and US wave via tested bone arrives from transmitter to Receiver. Simultaneously with US pulse, controller start timer to calculate time between US pulse and the moment that US wave arrives to receiver. The accepted US signal of selected probe via amplifiers arrives to comparators that read timer value. The microcontroller calculates SOS using distance between probes and US time of flight.
| Study group | Role | What they receive |
|---|---|---|
| bone age assessment by ultrasound | Other | The aim of this phase is to collect the ultrasound reading values of Speed of Sound (SOS) and Distance (DIS) of all participants by performing a one time measurement of the left hand by the SonicBone's BA device. Each measurement will be performed on three sites of the hand: the wrist the phalanx and the metacarpal bones. Receives: Device: SonicBone ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone age
The aim of this study is to establish a new bone age database by an ultrasound apparatus (SonicBone) that will eventually replace the X-ray based assessment using Greulich and Pyle and Tanner \& Whitehouse Atlas and methods.
Measured: 2 years ( 2013-2014)
bone age
To establish by an ultrasound apparatus (SonicBone's BAUS) a skeletal maturity (Bone Age) status database which corresponds with healthy children and adolescence.
To establish a conversion formula by an ultrasound apparatus results (SonicBone BAUS) for prediction of bone age assessment of healthy children and adolescence.
Measured: 2 years (2013-2014)
Secondary outcomes (1)
bone age
To investigate the pattern of skeletal maturation and ossification order of the three examined sites: Phalanx, Metacarpal and Wrist
Measured: 2 years (2013-2014)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Bone Age by Ultrasound TechnologyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herman Av Cohen, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980693
- Sponsor's protocol ID
- SonicBone Medical
- Other IDs
- SonicBone Medical
- Status last verified
- Apr 2013
- First submitted
- 17 Oct 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zou KH, Tuncali K, Silverman SG. Correlation and simple linear regression. Radiology. 2003 Jun;227(3):617-22. doi: 10.1148/radiol.2273011499.
PubMed 12773666Oostdijk W, Grote FK, de Muinck Keizer-Schrama SM, Wit JM. Diagnostic approach in children with short stature. Horm Res. 2009;72(4):206-17. doi: 10.1159/000236082. Epub 2009 Sep 29.
PubMed 19786792Baroncelli GI. Quantitative ultrasound methods to assess bone mineral status in children: technical characteristics, performance, and clinical application. Pediatr Res. 2008 Mar;63(3):220-8. doi: 10.1203/PDR.0b013e318163a286.
PubMed 18287958
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Investigate the Relationship Between Ultrasound Apparatus Results (SonicBone's BAUS) and Skeletal Maturity Status (Bone Age) Among Healthy Children and Adolescence
- ClinicalTrials.gov ID
- NCT01980693
- Acronym / sponsor ID
- SonicBone Medical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Nov 2013 (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.
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. 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.
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 new bone age database by an ultrasound apparatus (SonicBone) that will eventually replace the X-ray based assessment using Greulich and Pyle and Tanner \& Whitehouse Atlas and methods.
The design of the study is to perform a concomitant skeletal maturation assessment by reading of an ultrasound technique using the SonicBone apparatus. Skeletal maturation assessment will be performed in females and males at various age groups from 4-17 years old.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bone age assessment by ultrasound | Other | Device: SonicBone ultrasoundThe aim of this phase is to collect the ultrasound reading values of Speed of Sound (SOS) and Distance (DIS) of all participants by performing a one time measurement of the left hand by the SonicBone's BA device. Each measurement will be performed on three sites of the hand: the wrist the phalanx and the metacarpal bones. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 4-17 years old Children with normal (3%-97%) height values for their age Children with normal (3%-97%) weight values for their age Children with normal (5%-85%) BMI value for their age Children of Caucasian ethnical origin A signed Informed Consent Form that was obtained from at least one parent or legal guardian, prior to ultrasound study.
- An assent from the child to perform the SonicBone's BA device measurement
Key exclusion criteria (1 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, metabolic diseases, chronic 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonicBone ultrasoundAlso: SonicBone BA, SonicBone MedicalThe device measure BA using ultrasound technology by measurement of speed of sound in three different sites : wrist bones, Phalanx III, Metacarpal bones.The device sends a short US pulse and measures the distance between a transmitter probe and a receiver probe, located at the bone measured area.The US probe converts electrical pulse to US pulse and US wave via tested bone arrives from transmitter to Receiver. Simultaneously with US pulse, controller start timer to calculate time between US pulse and the moment that US wave arrives to receiver. The accepted US signal of selected probe via amplifiers arrives to comparators that read timer value. The microcontroller calculates SOS using distance between probes and US time of flight. | Device | bone age assessment by ultrasound |
Primary outcome
bone age
Time frame: 2 years ( 2013-2014)
The aim of this study is to establish a new bone age database by an ultrasound apparatus (SonicBone) that will eventually replace the X-ray based assessment using Greulich and Pyle and Tanner \& Whitehouse Atlas and methods.
bone age
Time frame: 2 years (2013-2014)
To establish by an ultrasound apparatus (SonicBone's BAUS) a skeletal maturity (Bone Age) status database which corresponds with healthy children and adolescence. To establish a conversion formula by an ultrasound apparatus results (SonicBone BAUS) for prediction of bone age assessment of healthy children and adolescence.
1 secondary outcome
bone age
Time frame: 2 years (2013-2014)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Background: PubMed 12773666Zou KH, Tuncali K, Silverman SG. Correlation and simple linear regression. Radiology. 2003 Jun;227(3):617-22. doi: 10.1148/radiol.2273011499.
- Background: PubMed 19786792Oostdijk W, Grote FK, de Muinck Keizer-Schrama SM, Wit JM. Diagnostic approach in children with short stature. Horm Res. 2009;72(4):206-17. doi: 10.1159/000236082. Epub 2009 Sep 29.
- Background: PubMed 18287958Baroncelli GI. Quantitative ultrasound methods to assess bone mineral status in children: technical characteristics, performance, and clinical application. Pediatr Res. 2008 Mar;63(3):220-8. doi: 10.1203/PDR.0b013e318163a286.
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.
Herman Av Cohen, MD principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonicBone ultrasound in people with Evaluation of Bone Age by Ultrasound Technology, run by Clalit Health Services 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cohen Av Herman, MD (972-3-9398200, hermanc@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone age (time frame: 2 years ( 2013-2014)). The study lists 2 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 NCT01980693, which also lists 3 linked publications.
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 Mar 2015.