Ultrasound Evaluation of Bone Age in Healthy Children

NCT01980693 | Unknown DMC

• 1 other identifier: SonicBone Medical
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Evaluation of Bone Age by Ultrasound Technology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 years (2013-2014)

Secondary Outcomes (1)

• bone age

  2 years (2013-2014)

Study Arms (1)

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.

Device: SonicBone ultrasound

Interventions

SonicBone ultrasound DEVICE

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.

Also known as: SonicBone BA, SonicBone Medical

bone age assessment by ultrasound

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clalit Health Services: lead

Study Sites (1)

Pediatric Community Ambulatory Clinic

Petah Tikva, Israel

RECRUITING

Related Publications (3)

• Zou KH, Tuncali K, Silverman SG. Correlation and simple linear regression. Radiology. 2003 Jun;227(3):617-22. doi: 10.1148/radiol.2273011499.

  PMID: 12773666 BACKGROUND

• Oostdijk 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.

  PMID: 19786792 BACKGROUND

• Baroncelli 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.

  PMID: 18287958 BACKGROUND

Study Officials

• Herman Av Cohen, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cohen Av Herman, MD

CONTACT

972-3-9398200; hermanc@post.tau.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: November 11, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 6, 2015

Record last verified: 2013-04

Locations

IL (1)