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Multicenter Bone and Joint Health Study (MOST)

12. februar 2021 opdateret af: University of California, San Francisco

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

4185

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52240
        • University of Iowa
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria for "New Cohort" Participants:

  • Age 45 to 69 Years (Adult, Senior)
  • Males and Females
  • Healthy Volunteers
  • Community-based Sample

Exclusion Criteria for "New Cohort" Participants:

  • 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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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].

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Worsening knee pain
Tidsramme: 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
Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Incident cartilage loss on MRI
Tidsramme: Change from baseline (144-month) at 168-month follow-up contact
Incidence of cartilage loss on MRI extending to the bone
Change from baseline (144-month) at 168-month follow-up contact
Function loss
Tidsramme: 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
Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Onset of constant knee pain
Tidsramme: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Self- report
Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Worsening on MRI
Tidsramme: Change from baseline (144-month) at 168-month follow-up contact
Worsening cartilage scores, bone marrow lesion, or meniscal damage
Change from baseline (144-month) at 168-month follow-up contact
Worsening on X-ray
Tidsramme: Change from baseline (144-month) at 168-month follow-up contact
Increased Kellgren-Lawrence (KL) grade score, new KL grade 2 score, or semi-quantitative joint space loss in any compartment
Change from baseline (144-month) at 168-month follow-up contact
New onset knee buckling
Tidsramme: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
Self-report
Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
New repeated falls
Tidsramme: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
Self-report
Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

Boston University
University of Alabama at Birmingham
University of Iowa
National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Michael Nevitt, PhD, University of California, San Francisco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2003

Primær færdiggørelse (Faktiske)

1. december 2020

Studieafslutning (Faktiske)

1. december 2020

Datoer for studieregistrering

Først indsendt

1. december 2016

Først indsendt, der opfyldte QC-kriterier

24. januar 2017

Først opslået (Skøn)

26. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • U01AG019069 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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).

IPD-delingsadgangskriterier

See NIA Biobank website

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsor / samarbejdspartnere

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