OsteoarthritisNCT07006701
A Population-based Cohort of Osteoarthritis: the Tsinghua University Tiantongyuan Community Osteoarthritis Study
An observational study of Osteoarthritis, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
The purpose of this study is to examine the natural history and risk factors of osteoarthritis (OA) and to explore the relationship between metabolic factors and OA progression. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2025to 31 Dec 2034
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: This study will include adults aged 50 years and above to investigate osteoarthritis risk factors and progression in a general population-based cohort.
Who may be able to join
- Aged 50 years and above
- Long-term resident of the study area
- Willing to participate and provide informed consent
Who cannot join
- Hearing, speech, or mental impairments preventing effective communication
- Unable to complete scheduled follow-up visits
- Pregnant or planning pregnancy during the study period
- Any other condition deemed unsuitable for participation by the researchers
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
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218
About this study
The purpose of this study is to examine the natural history and risk factors of osteoarthritis (OA) and to explore the relationship between metabolic factors and OA progression.
Read the detailed description
- To investigate the natural history of osteoarthritis (OA) in a large-sample cohort.
- To identify OA phenotypes and their relationship with clinical symptoms and functional impairment.
- To analyze metabolic factors (e.g., obesity, diabetes, and hypertension) as risk factors for OA onset and progression.
- To evaluate the association between radiographic changes and OA symptoms.
- To develop predictive models for OA progression and identify high-risk individuals for early intervention.
Design: This is a prospective cohort study. Participants: The study will recruit approximately 4,000 individuals aged 50 years and above. Participants will undergo baseline assessments, including demographic data collection, medical history, dietary evaluation, physical examination, blood sample collection, and radiographic imaging. Annual follow-ups will be conducted over 10 years to monitor OA progression and related risk factors.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Osteoarthritis
The occurrence of clinically diagnosed osteoarthritis based on imaging and clinical symptoms during the follow-up period.
Measured: Annually for 10 years
Secondary outcomes (13)
Change in Joint Pain Severity (WOMAC Pain Subscale)
Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range: 0-20). Higher scores indicate worse pain.
Measured: Annually for 10 years
Change in Physical Function (WOMAC Subscale)
Assessed using the WOMAC physical function subscale (range: 0-68). Higher scores indicate worse physical function.
Measured: Annually for 10 years
Change in Physical Function (SF-36 Physical Function Domain)
Assessed using the SF-36 physical function domain (range: 0-100). Higher scores indicate better physical function.
Measured: Annually for 10 years
Timed Up and Go Test (TUGT)
Measured in seconds; a shorter time indicates better mobility.
Measured: Annually for 10 years
Five Times Sit-to-Stand Test (5TSTS)
Measured in seconds; a shorter time indicates better lower limb strength and function.
Measured: Annually for 10 years
Radiographic Progression of Osteoarthritis
Measured by changes in Kellgren-Lawrence (K-L) grade in bilateral knee X-rays over time.
Measured: Annually for 10 years
Changes in Body Mass Index (BMI)
Measured in kg/m². Analyzed for correlation with radiographic progression of osteoarthritis using the Kellgren-Lawrence grading system.
Measured: Annually for 10 years
Changes in Blood Pressure
Measured in mmHg using an automated sphygmomanometer to record systolic and diastolic blood pressure.
Measured: Annually for 10 years
Changes in Fasting Glucose
Measured in mg/dL using venous blood samples collected after an overnight fast.
Measured: Annually for 10 years
Changes in Total Cholesterol (TC)
Measured in mmol/L or mg/dL using fasting venous blood samples.
Measured: Annually for 10 years
Changes in Low-Density Lipoprotein Cholesterol (LDL-C)
Measured in mmol/L or mg/dL using fasting venous blood samples.
Measured: Annually for 10 years
Changes in High-Density Lipoprotein Cholesterol (HDL-C)
Measured in mmol/L or mg/dL using fasting venous blood samples.
Measured: Annually for 10 years
Changes in Triglycerides (TG)
Measured in mmol/L or mg/dL using fasting venous blood samples.
Measured: Annually for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start3 Jun 2025 (estimated)
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006701
- Sponsor's protocol ID
- 25025-4-01
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 5 Jun 2025
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-based Cohort of Osteoarthritis: the Tsinghua University Tiantongyuan Community Osteoarthritis Study
- ClinicalTrials.gov ID
- NCT07006701
- Acronym / sponsor ID
- 25025-4-01
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 3 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 5 Jun 2025 (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 purpose of this study is to examine the natural history and risk factors of osteoarthritis (OA) and to explore the relationship between metabolic factors and OA progression.
Detailed description
- To investigate the natural history of osteoarthritis (OA) in a large-sample cohort.
- To identify OA phenotypes and their relationship with clinical symptoms and functional impairment.
- To analyze metabolic factors (e.g., obesity, diabetes, and hypertension) as risk factors for OA onset and progression.
- To evaluate the association between radiographic changes and OA symptoms.
- To develop predictive models for OA progression and identify high-risk individuals for early intervention.
Design: This is a prospective cohort study. Participants: The study will recruit approximately 4,000 individuals aged 50 years and above. Participants will undergo baseline assessments, including demographic data collection, medical history, dietary evaluation, physical examination, blood sample collection, and radiographic imaging. Annual follow-ups will be conducted over 10 years to monitor OA progression and related risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will include adults aged 50 years and above to investigate osteoarthritis risk factors and progression in a general population-based cohort.
Key inclusion criteria (3 listed)
- Aged 50 years and above
- Long-term resident of the study area
- Willing to participate and provide informed consent
Key exclusion criteria (4 listed)
- Hearing, speech, or mental impairments preventing effective communication
- Unable to complete scheduled follow-up visits
- Pregnant or planning pregnancy during the study period
- Any other condition deemed unsuitable for participation by the researchers
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
Incidence of Osteoarthritis
Time frame: Annually for 10 years
The occurrence of clinically diagnosed osteoarthritis based on imaging and clinical symptoms during the follow-up period.
13 secondary outcomes
Change in Joint Pain Severity (WOMAC Pain Subscale)
Time frame: Annually for 10 years
Change in Physical Function (WOMAC Subscale)
Time frame: Annually for 10 years
Change in Physical Function (SF-36 Physical Function Domain)
Time frame: Annually for 10 years
Timed Up and Go Test (TUGT)
Time frame: Annually for 10 years
Five Times Sit-to-Stand Test (5TSTS)
Time frame: Annually for 10 years
Radiographic Progression of Osteoarthritis
Time frame: Annually for 10 years
Changes in Body Mass Index (BMI)
Time frame: Annually for 10 years
Changes in Blood Pressure
Time frame: Annually for 10 years
Changes in Fasting Glucose
Time frame: Annually for 10 years
Changes in Total Cholesterol (TC)
Time frame: Annually for 10 years
Changes in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Annually for 10 years
Changes in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Annually for 10 years
Changes in Triglycerides (TG)
Time frame: Annually for 10 years
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 5 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, run by Beijing Tsinghua Chang Gung 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Jun 2025. 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?
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?
Incidence of Osteoarthritis (time frame: Annually for 10 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 5 Jun 2025.