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Clinical Trials/NCT03190109
NCT03190109
Unknown
Not Applicable

Analyses of Bone Age Determined by Ultrasound in a Cohort of Brazilian Control Children and Adolescents: Comparison With Conventional Bone Age Determined by X-Ray

Faculdade de Ciências Médicas da Santa Casa de São Paulo1 site in 1 country500 target enrollmentOctober 13, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Control, Population
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Enrollment
500
Locations
1
Primary Endpoint
bone age determination by ultrasound (BAUS)
Last Updated
8 years ago

Overview

Brief Summary

Aiming to validate the use of bone age determined by ultrasound (BAUS) in Brazilian children, normal control students will be studied. X-Ray bone age (RXBA) and BAUS will be determined in 500 children and adolescents of both genders, with chronological age varying from 6-16 years.

Concordance analysis and the correlation between both BA determination methods will be performed.

Detailed Description

Bone age is a valuable method to recognize the maturation status of development and growth. Classical analyses is performed by using the Greulich and Pyle X-Ray measurement. Such analyses have some restrictions such as intra- and inter observer variability, and variable synchronicity of bone maturation. Bone age determined by ultrasound (BAUS) has been indicated as a fast and reproducible method, allowing decimal BA determination and avoiding the need for X-Ray. Our aim is to validate the BAUS method in Brazilian normal controls. School students of both genders, with age varying from 6 to 16 years will be included.

Registry
clinicaltrials.gov
Start Date
October 13, 2016
End Date
March 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Carlos Alberto Longui

Full Professor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Eligibility Criteria

Inclusion Criteria

  • absence of chronic illness and drug ingestion

Exclusion Criteria

  • any chronic disease or medicine use
  • body mass index: \< -2SDS or \> +2SDS
  • stature : \< -2SDS or \> +2SDS

Outcomes

Primary Outcomes

bone age determination by ultrasound (BAUS)

Time Frame: chronological ages between 6 and 16 years of age

Determination of bone age in years by employing a ultrasound device

Study Sites (1)

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