Bone Age of Chinese Child (BACC) (BACC)

The National Survey on Bone Age of Child in China

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 20166

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100035
      • Beijing Jishuitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

As part of the "National Nutrition and Health Systematic Survey for 0-18 years old Children and Utilization of Survey Findings" (ChiCTR1900022825). This population is the subset of the ChiCTR1900022825 study, age 3-18 years old, sample proportion to the general study population. General healthy children age over 3 years old up to 18 years old from the kindergarden, primary school, middle school and high school.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the bone age of the wrist and hand	The bone age assessed by radiologist with the hand and wrist X-ray	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Collaborators: 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 record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2019
• Primary Completion (ACTUAL): October 16, 2021
• Study Completion (ACTUAL): November 16, 2021

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: bone age; bone mineral density; X-ray; Chinese child
• Other Study ID Numbers: JST2019BA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No