Bone DevelopmentBACCNCT04197557
Bone Age of Chinese Child (BACC)
An observational study of Bone Development, run by Beijing Jishuitan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Development
- How many people
- 20,166 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2019to 16 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- participants of ChiCTR1900022825 study
- healthy children age 3 to 18 years old.
- willing to participate this study
- Consent by parents
Who cannot join
- no consent by parents
- under 3 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Development
- Keywords
- bone age, bone mineral density, X-ray, Chinese child
What is being measured
The primary outcome is the main question the study is designed to answer.
the bone age of the wrist and hand
The bone age assessed by radiologist with the hand and wrist X-ray
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start26 Aug 2019
- Primary completion16 Oct 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nationtial Institute of Nutrition and Health, China CDC, Beijing pediatric research institute
- Responsible party
- Principal investigator, xiaoguang Cheng, Beijing Jishuitan Hospital
- Investigators
- xiaoguang cheng, MD, Principal investigator, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197557
- Sponsor's protocol ID
- JST2019BA
- Acronym
- BACC
- Status last verified
- Nov 2021
- First submitted
- 11 Dec 2019
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Survey on Bone Age of Child in China
- ClinicalTrials.gov ID
- NCT04197557
- Acronym / sponsor ID
- BACC / JST2019BA
- Conditions
- Bone Development
- Keywords
- bone age, bone mineral density, X-ray, Chinese child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,166 participants (actual)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- Nationtial Institute of Nutrition and Health, China CDC, Beijing pediatric research institute
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 16 Oct 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- participants of ChiCTR1900022825 study
- healthy children age 3 to 18 years old.
- willing to participate this study
- Consent by parents
Key exclusion criteria (2 listed)
- no consent by parents
- under 3 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the bone age of the wrist and hand
Time frame: 3 years
The bone age assessed by radiologist with the hand and wrist X-ray
1 secondary outcome
bone mineral density (BMD)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaoguang cheng, MD principal investigator
Beijing Jishuitan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Development, run by Beijing Jishuitan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the bone age of the wrist and hand (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.