Clinical trial NCT07006701: A Population-based Cohort of Osteoarthritis: the Tsinghua University Tiantongyuan Community Osteoarthritis Study
Official title: A Population-based Cohort of Osteoarthritis: the Tsinghua University Tiantongyuan Community Osteoarthritis Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 4000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

Detailed description: 1. To investigate the natural history of osteoarthritis (OA) in a large-sample cohort.
2. To identify OA phenotypes and their relationship with clinical symptoms and functional impairment.
3. To analyze metabolic factors (e.g., obesity, diabetes, and hypertension) as risk factors for OA onset and progression.
4. To evaluate the association between radiographic changes and OA symptoms.
5. 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.

Eligibility criteria: Inclusion Criteria:

* Aged 50 years and above
* Long-term resident of the study area
* Willing to participate and provide informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Osteoarthritis
timeFrame: Annually for 10 years
Secondary outcomes:
measure: Change in Joint Pain Severity (WOMAC Pain Subscale)
timeFrame: Annually for 10 years
measure: Change in Physical Function (WOMAC Subscale)
timeFrame: Annually for 10 years
measure: Change in Physical Function (SF-36 Physical Function Domain)
timeFrame: Annually for 10 years
measure: Timed Up and Go Test (TUGT)
timeFrame: Annually for 10 years
measure: Five Times Sit-to-Stand Test (5TSTS)
timeFrame: Annually for 10 years
measure: Radiographic Progression of Osteoarthritis
timeFrame: Annually for 10 years
measure: Changes in Body Mass Index (BMI)
timeFrame: Annually for 10 years
measure: Changes in Blood Pressure
timeFrame: Annually for 10 years
measure: Changes in Fasting Glucose
timeFrame: Annually for 10 years
measure: Changes in Total Cholesterol (TC)
timeFrame: Annually for 10 years
measure: Changes in Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Annually for 10 years
measure: Changes in High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Annually for 10 years
measure: Changes in Triglycerides (TG)
timeFrame: Annually for 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
state: Beijing
Study officials:
References: