OsteoporosisNCT05906147
Health ImprOvement Program of Bone in China
An observational study of Osteoporosis, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Fracture risk factors have long been identified as key factors in osteoporosis and fragility fractures. The WHO recommended Fracture risk assessmenttool (FRAX) applies clinical risk factors to assess the absolute risk of osteoporotic fractures in each individual. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Regular follow-up
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2021to 27 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 100 years
- All sexes
- Adult, Older adult
Study population: Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old
Who may be able to join
- Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old. Have independent civil capacity and agree to participate, and sign informed consent
Who cannot join
- Under 40 years of age， Patients who had undergone hip replacement or lumbar surgery and could not perform dual-energy X-ray BMD testing; Patients who have been treated with effective anti-osteoporosis drugs or have a history of malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Health Management Center, The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
zhifeng sheng, doctorate, 008613574806523, shengzhifeng@csu.edu.cn
About this study
Fracture risk factors have long been identified as key factors in osteoporosis and fragility fractures. The WHO recommended Fracture risk assessmenttool (FRAX) applies clinical risk factors to assess the absolute risk of osteoporotic fractures in each individual. Our preliminary study suggests that FRAX estimates may underestimate the risk of fractures in the Chinese population. In order to optimize the risk prediction model of osteoporotic fractures, a treatment threshold and its optimal cutting point were initially established based on the data of the health management Center of the Second Xiangya Hospital of Central South University.
- Conditions
- Osteoporosis
- Being tested
- Regular follow-up
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular follow-upOther
Follow-up of the population was conducted to track the incidence of fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density bone mineral density
Bone mineral density (BMD) data measured by dual-energy X-ray absorptiometry were collected from patients over 40 years old
Measured: From 2021 to 2031
Occurrence of fracture
Follow-up of the population was conducted to track the incidence of fractures
Measured: From 2021 to 2031
clinical risk factors of osteoporotic fracture
The main clinical risk factors of osteoporotic fracture were collected
Measured: From 2021 to 2031
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start27 Feb 2021
- Primary completion27 Feb 2021
- Study completion27 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sheng zhifeng, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906147
- Sponsor's protocol ID
- LYF2021015.
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yue C, Li YF, Xu LL, Wang QY, Yang YY, Sheng ZF. Develop a bone mineral density T-score distribution nomograms based on osteoporosis risk factors for middle-aged and older adults. Geriatr Nurs. 2024 Jul-Aug;58:344-351. doi: 10.1016/j.gerinurse.2024.06.010. Epub 2024 Jun 13.
PubMed 38875761
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health ImprOvement Program of Bone in China
- ClinicalTrials.gov ID
- NCT05906147
- Acronym / sponsor ID
- LYF2021015.
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 27 Feb 2021 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 27 Feb 2031 (estimated)
- First posted
- 15 Jun 2023 (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.
Fracture risk factors have long been identified as key factors in osteoporosis and fragility fractures. The WHO recommended Fracture risk assessmenttool (FRAX) applies clinical risk factors to assess the absolute risk of osteoporotic fractures in each individual. Our preliminary study suggests that FRAX estimates may underestimate the risk of fractures in the Chinese population. In order to optimize the risk prediction model of osteoporotic fractures, a treatment threshold and its optimal cutting point were initially established based on the data of the health management Center of the Second Xiangya Hospital of Central South University.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old
Key inclusion criteria (1 listed)
- Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old. Have independent civil capacity and agree to participate, and sign informed consent
Key exclusion criteria (1 listed)
- Under 40 years of age， Patients who had undergone hip replacement or lumbar surgery and could not perform dual-energy X-ray BMD testing; Patients who have been treated with effective anti-osteoporosis drugs or have a history of malignant tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular follow-upFollow-up of the population was conducted to track the incidence of fractures | Other | – |
Primary outcome
bone mineral density bone mineral density
Time frame: From 2021 to 2031
Bone mineral density (BMD) data measured by dual-energy X-ray absorptiometry were collected from patients over 40 years old
Occurrence of fracture
Time frame: From 2021 to 2031
Follow-up of the population was conducted to track the incidence of fractures
clinical risk factors of osteoporotic fracture
Time frame: From 2021 to 2031
The main clinical risk factors of osteoporotic fracture were collected
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 38875761Yue C, Li YF, Xu LL, Wang QY, Yang YY, Sheng ZF. Develop a bone mineral density T-score distribution nomograms based on osteoporosis risk factors for middle-aged and older adults. Geriatr Nurs. 2024 Jul-Aug;58:344-351. doi: 10.1016/j.gerinurse.2024.06.010. Epub 2024 Jun 13.
- Individual participant dataSharing planned: Undecided
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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.
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 Osteoporosis, run by Second Xiangya Hospital of Central South University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Jun 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhifeng sheng, doctorate (008613574806523, shengzhifeng@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density bone mineral density (time frame: From 2021 to 2031). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05906147, which also lists 1 linked publication.
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 15 Jun 2023.