Bone Age of Chinese Child (BACC)

Sponsor

Beijing Jishuitan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04197557

Collaborator

National Institute for Nutrition and Health Chinese Center for Disease Control and Prevention (Other), Beijing pediatric research institute (Other)

20,166

Enrollment

Location

26.7

Actual Duration (Months)

755

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The bone age of the hand and wrist will be assessed with X-rays in more than 20,000 healthy children age 3-18 years old recruited in 28 sites from 14 province.The bone mineral density (BMD) will be measured as well.

Condition or Disease	Intervention/Treatment	Phase
Bone Development

Detailed Description

As part of the "National Nutrition and Health Systematic Survey for 0-18 years old Children and Utilization of Survey Findings "(ChiCTR1900022825), more than 20,000 children age 3-18 years old was recruited from 28 sites of 14 provinces within the framework of the ChiCTR190002282 study protocol. The population of this study was proportional to the ChiCTR190002282 study. The X-ray of no-dominant hand and wrist was taken with a mobile X-ray unit with shielding. A step wedge was imaged along the side of the hand at the same time for bone mineral density measurement. The bone age of the hand and wrist was assessed by trained MSK radiologists according to Chinese standard. The bone mineral density of the wrist was measured with radioabsorptiometry (RA). The demographic parameters were collected by the study of ChiCTR190002282 protocol.

Study Design

Study Type:

Observational

Actual Enrollment :

20166 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

The National Survey on Bone Age of Child in China

Actual Study Start Date :

Aug 26, 2019

Actual Primary Completion Date :

Oct 16, 2021

Actual Study Completion Date :

Nov 16, 2021

Outcome Measures

Primary Outcome Measures

the bone age of the wrist and hand [3 years]
The bone age assessed by radiologist with the hand and wrist X-ray

Secondary Outcome Measures

bone mineral density (BMD) [3 years]
The bone mineral density (BMD) measured with the wrist and hand X-ray The bone mineral density (BMD) measured with the wrist and hand X-ray calibrated with a step wedge

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

participants of ChiCTR1900022825 study
healthy children age 3 to 18 years old.
willing to participate this study
Consent by parents

Exclusion Criteria:

no consent by parents
under 3 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Jishuitan hospital	Beijing	Beijing	China	100035

Sponsors and Collaborators

Beijing Jishuitan Hospital
National Institute for Nutrition and Health Chinese Center for Disease Control and Prevention
Beijing pediatric research institute

Investigators

Principal Investigator: xiaoguang cheng, MD, Beijing Jishuitan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

xiaoguang Cheng, Professor, chairman of Radiology Department, Beijing Jishuitan Hospital

ClinicalTrials.gov Identifier:

NCT04197557

Other Study ID Numbers:

JST2019BA

First Posted:

Dec 13, 2019

Last Update Posted:

Nov 23, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by xiaoguang Cheng, Professor, chairman of Radiology Department, Beijing Jishuitan Hospital

Study Results

No Results Posted as of Nov 23, 2021