Osteoarthritis,KneeMOSTNCT03033238
Multicenter Bone and Joint Health Study
An observational study of Osteoarthritis,Knee, run by University of California, San Francisco at 3 sites in United States.
Trial summary
The purpose of this study is to investigate opportunities for prevention and treatment of knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and poor pain and physical function outcomes especially among those with early or mild knee symptoms. Read more about this study
- Who is it for?
- Ages 45 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis,Knee
- How many people
- 4,185 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2003to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The purpose of this study is to investigate opportunities for prevention and treatment of knee osteoarthritis by evaluating potentially modifiable risk factors for disease and poor pain and physical function outcomes especially among those with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage and to limit the impact of disease once it has occurred.
Who may be able to join
- Age 45 to 69 Years (Adult, Senior)
- Males and Females
- Healthy Volunteers
- Community-based Sample
Who cannot join
- Rheumatoid or inflammatory arthritis (based on self-report and use of medications specific to these conditions)
- Serious health condition e.g., end-stage renal disease, etc. that would likely limit follow-up to less than 2-3 years
- Plan to relocate out of geographic region in next 3 years
- Not able to walk without the aid of a person or assistive device
- Knee joint replacement surgery in either knee
- Neither knee fits in the MRI knee coil (determined during Screening Visit).
- Not competent to give informed consent
- Advanced structural tibiofemoral or patellofemoral knee OA disease (KL grade 3 or 4) in either knee (Determined by Knee X-ray Screening)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston University School of Medicine
Boston, Massachusetts, 02118
University of Iowa
Iowa City, Iowa, 52240
About this study
Official title: Multicenter Osteoarthritis Study (MOST) Second Renewal
The purpose of this study is to investigate opportunities for prevention and treatment of knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and poor pain and physical function outcomes especially among those with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage and to limit the impact of disease once it has occurred.
Read the detailed description
MOST study participants in the "Existing Cohort" (3,026 subjects) were enrolled in the original study in 2003-2005. Surviving Existing Cohort participants without end-stage knee osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up contacts. In addition, in 2016-2018 the cohort will be enriched by the recruitment of an additional 1,500 "New Cohort" participants with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage.
- Conditions
- Osteoarthritis,Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early or mild knee symptoms | Existing Cohort study participants (3,026) were enrolled in 2003-2005, Surviving participants without endstage knee osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up contacts [2,660 were enrolled]. New Cohort study participants (1,500) will be recruited and enrolled in 2016-2018 [1,525 were enrolled]. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening knee pain
Worsening knee pain defined as reaching minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire
Measured: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Incident cartilage loss on MRI
Incidence of cartilage loss on MRI extending to the bone
Measured: Change from baseline (144-month) at 168-month follow-up contact
Function loss
Defined as minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function questionnaire
Measured: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Secondary outcomes (5)
Onset of constant knee pain
Self- report
Measured: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Worsening on MRI
Worsening cartilage scores, bone marrow lesion, or meniscal damage
Measured: Change from baseline (144-month) at 168-month follow-up contact
Worsening on X-ray
Increased Kellgren-Lawrence (KL) grade score, new KL grade 2 score, or semi-quantitative joint space loss in any compartment
Measured: Change from baseline (144-month) at 168-month follow-up contact
New onset knee buckling
Self-report
Measured: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
New repeated falls
Self-report
Measured: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2003
- Primary completionDec 2020
- Study completionDec 2020
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 Osteoarthritis,KneeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 4,185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Alabama at Birmingham, Boston University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Michael Nevitt, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033238
- Sponsor's protocol ID
- U01AG019069
- Other IDs
- U01AG019069
- Acronym
- MOST
- Status last verified
- Feb 2021
- First submitted
- 1 Dec 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized clinical data will be shared via The NIA Biobank (https://agingresearchbiobank.nia.nih.gov/). MOST Existing Cohort data from previous grant cycles will be available in mid 2021. For more information visit MOST Online (https://most.ucsf.edu).
Publications
Rabe KG, Stockman TJ, Kern AM, Wirth W, Eckstein F, Sharma L, Lynch JA, Nevitt MC, Anderson DD, Segal NA. Longitudinal Relationship Between Tibiofemoral Contact Stress at Baseline and Worsening of Knee Pain Over 84 Months in the Multicenter Osteoarthritis Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):726-732. doi: 10.1097/PHM.0000000000001899. Epub 2021 Oct 8.
PubMed 34620738
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Osteoarthritis Study (MOST) Second Renewal
- ClinicalTrials.gov ID
- NCT03033238
- Acronym / sponsor ID
- MOST / U01AG019069
- Conditions
- Osteoarthritis,Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,185 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Iowa, University of Alabama at Birmingham, Boston University, National Institute on Aging (NIA)
- Study start
- Jan 2003
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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 investigate opportunities for prevention and treatment of knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and poor pain and physical function outcomes especially among those with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage and to limit the impact of disease once it has occurred.
Detailed description
MOST study participants in the "Existing Cohort" (3,026 subjects) were enrolled in the original study in 2003-2005. Surviving Existing Cohort participants without end-stage knee osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up contacts. In addition, in 2016-2018 the cohort will be enriched by the recruitment of an additional 1,500 "New Cohort" participants with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early or mild knee symptoms | – | –Existing Cohort study participants (3,026) were enrolled in 2003-2005, Surviving participants without endstage knee osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up contacts [2,660 were enrolled]. New Cohort study participants (1,500) will be recruited and enrolled in 2016-2018 [1,525 were enrolled]. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The purpose of this study is to investigate opportunities for prevention and treatment of knee osteoarthritis by evaluating potentially modifiable risk factors for disease and poor pain and physical function outcomes especially among those with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage and to limit the impact of disease once it has occurred.
Key inclusion criteria (4 listed)
- Age 45 to 69 Years (Adult, Senior)
- Males and Females
- Healthy Volunteers
- Community-based Sample
Key exclusion criteria (8 listed)
- Rheumatoid or inflammatory arthritis (based on self-report and use of medications specific to these conditions)
- Serious health condition e.g., end-stage renal disease, etc. that would likely limit follow-up to less than 2-3 years
- Plan to relocate out of geographic region in next 3 years
- Not able to walk without the aid of a person or assistive device
- Knee joint replacement surgery in either knee
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
Worsening knee pain
Time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Worsening knee pain defined as reaching minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire
Incident cartilage loss on MRI
Time frame: Change from baseline (144-month) at 168-month follow-up contact
Incidence of cartilage loss on MRI extending to the bone
Function loss
Time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Defined as minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function questionnaire
5 secondary outcomes
Onset of constant knee pain
Time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Worsening on MRI
Time frame: Change from baseline (144-month) at 168-month follow-up contact
Worsening on X-ray
Time frame: Change from baseline (144-month) at 168-month follow-up contact
New onset knee buckling
Time frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
New repeated falls
Time frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 34620738Rabe KG, Stockman TJ, Kern AM, Wirth W, Eckstein F, Sharma L, Lynch JA, Nevitt MC, Anderson DD, Segal NA. Longitudinal Relationship Between Tibiofemoral Contact Stress at Baseline and Worsening of Knee Pain Over 84 Months in the Multicenter Osteoarthritis Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):726-732. doi: 10.1097/PHM.0000000000001899. Epub 2021 Oct 8.
- Individual participant dataSharing planned: Yes. Anonymized clinical data will be shared via The NIA Biobank (https://agingresearchbiobank.nia.nih.gov/). MOST Existing Cohort data from previous grant cycles will be available in mid 2021. For more information visit MOST Online (https://most.ucsf.edu).
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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. This study is not recruiting at the moment.
Michael Nevitt, PhD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis,Knee, run by University of California, San Francisco at 3 sites in United States.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Worsening knee pain (time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)). 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 NCT03033238, 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 16 Feb 2021.