Bone Age of Chinese Child (BACC)

Bone Development Clinical Trial

— BACC  

Official title:

The National Survey on Bone Age of Child in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197557
• Other study ID #: JST2019BA
• Status: Completed
• Start date: August 26, 2019
• Est. completion date: November 16, 2021

Study information

• Verified date: November 2021
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20166
• Est. completion date: November 16, 2021
• Est. primary completion date: October 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Development

Locations

Country	Name	City	State
China	Beijing Jishuitan hospital	Beijing	Beijing

Sponsors (3)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the bone age of the wrist and hand	The bone age assessed by radiologist with the hand and wrist X-ray	3 years
Secondary	bone mineral density (BMD)	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	3 years