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NCT Number: NCT07006701

A Population-based Cohort of Osteoarthritis: the Tsinghua University Tiantongyuan Community Osteoarthritis 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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

About this study

  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Joint Pain Severity (WOMAC Pain Subscale)

    Time frame: Annually for 10 years

    Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range: 0-20). Higher scores indicate worse pain.

  2. Change in Physical Function (WOMAC Subscale)

    Time frame: Annually for 10 years

    Assessed using the WOMAC physical function subscale (range: 0-68). Higher scores indicate worse physical function.

  3. Change in Physical Function (SF-36 Physical Function Domain)

    Time frame: Annually for 10 years

    Assessed using the SF-36 physical function domain (range: 0-100). Higher scores indicate better physical function.

  4. Timed Up and Go Test (TUGT)

    Time frame: Annually for 10 years

    Measured in seconds; a shorter time indicates better mobility.

  5. Five Times Sit-to-Stand Test (5TSTS)

    Time frame: Annually for 10 years

    Measured in seconds; a shorter time indicates better lower limb strength and function.

  6. Radiographic Progression of Osteoarthritis

    Time frame: Annually for 10 years

    Measured by changes in Kellgren-Lawrence (K-L) grade in bilateral knee X-rays over time.

  7. Changes in Body Mass Index (BMI)

    Time frame: Annually for 10 years

    Measured in kg/m². Analyzed for correlation with radiographic progression of osteoarthritis using the Kellgren-Lawrence grading system.

  8. Changes in Blood Pressure

    Time frame: Annually for 10 years

    Measured in mmHg using an automated sphygmomanometer to record systolic and diastolic blood pressure.

  9. Changes in Fasting Glucose

    Time frame: Annually for 10 years

    Measured in mg/dL using venous blood samples collected after an overnight fast.

  10. Changes in Total Cholesterol (TC)

    Time frame: Annually for 10 years

    Measured in mmol/L or mg/dL using fasting venous blood samples.

  11. Changes in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Annually for 10 years

    Measured in mmol/L or mg/dL using fasting venous blood samples.

  12. Changes in High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Annually for 10 years

    Measured in mmol/L or mg/dL using fasting venous blood samples.

  13. Changes in Triglycerides (TG)

    Time frame: Annually for 10 years

    Measured in mmol/L or mg/dL using fasting venous blood samples.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2034
Study completion
2034
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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