NCT04033757

Brief Summary

The purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (OA) and pain at different joints, and to examine the association between OA structure changes, inflammation and pain for knee and hand OA.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,080

participants targeted

Target at P75+ for all trials

Timeline
65mo left

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Nov 2015Dec 2031

Study Start

First participant enrolled

November 17, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

April 11, 2022

Status Verified

March 1, 2022

Enrollment Period

16 years

First QC Date

July 4, 2019

Last Update Submit

March 31, 2022

Conditions

Osteoarthritis

Keywords

osteoarthritiscohort studypopulation-based

Outcome Measures

Primary Outcomes (3)

  • Prevalence of multiple joints osteoarthritis.

    Measured by radiographs of multiple joints.

    At enrollment.

  • Incidence of multiple joints osteoarthritis.

    Measured by radiographs of multiple joints, and the incidence of osteoarthritis can be calculated at each follow-up time point.

    At 3, 6, 9, 12 years follow-ups after enrollment.

  • Progression of multiple joints osteoarthritis.

    The changes of joint space and osteophytes are measured by radiographs of multiple joints, to assess the progression of multiple joints osteoarthritis.

    At 3, 6, 9, 12 years follow-ups after enrollment.

Secondary Outcomes (31)

  • Ultrasound detected changes of knee, thigh muscle, and hand.

    At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

  • Changes of pain intensity of knee, hip, hand and lumbar.

    At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

  • Changes of pain experience of knee.

    At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

  • Changes of neuropathic pain of knee.

    At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

  • Changes of patient's belief about knee pain.

    At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

  • +26 more secondary outcomes

Study Arms (3)

Sub-cohort 1

1,469 participants were enrolled in 2015. Three follow-ups have been completed in 2016, 2017, and 2020. They will be asked to participate in follow-up in 2023 and 2026.

Sub-cohort 2

1,267 participants were enrolled in 2018. They will be asked to participate in follow-up in 2021, 2024, 2027, and 2030.

Sub-cohort 3

1,340 participants were enrolled in 2019. They will be asked to participate in follow-up in 2022, 2025, 2028, and 2031.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects included in this study were a randomly selected sample of residents, aged 50 years or older, from rural mountainous communities of Longshan County, Hunan Province, China.

You may qualify if:

  • years old or above
  • Residents of the randomly selected communities

You may not qualify if:

  • Inability to give informed consent
  • Terminal or mental illness
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Related Publications (1)

  • Zhu Y, Li J, Zhang Y, Zhang W, Doherty M, Yang Z, Cui Y, Zeng C, Lei G, Yang T, Wei J. Association between hyperuricaemia and hand osteoarthritis: data from the Xiangya Osteoarthritis Study. RMD Open. 2023 Dec 1;9(4):e003683. doi: 10.1136/rmdopen-2023-003683.

    PMID: 38053456DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool, saliva, dental plaque

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Guanghua Lei, Doctor

    Xiangya Hospital of Central South University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 26, 2019

Study Start

November 17, 2015

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

April 11, 2022

Record last verified: 2022-03

Locations

CN(1)