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<docDscr>
  <citation>
    <titlStmt>
      <titl>Estimation via the WHO index (FRAX®) of the risk of fracture by bone fragility in French women</titl>
      <IDNo>FRESH-PEF86-en</IDNo>
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  <citation>
    <titlStmt>
      <titl>
                Estimation via the WHO index (FRAX®) of the risk of fracture by bone fragility in French women            </titl>
      <altTitl>
                    FRAG'OS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF86-en            </IDNo>
      <IDNo agency="PEF">
                    86                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF86                </IDNo>
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      <AuthEnty>
                    Franck VIGNAL                                                                                                                            </AuthEnty>
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    <prodStmt>
      <producer role="sponsor">
                                            SANOFI (FRANCE)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
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    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="SANOFI (FRANCE)" email="franck.vignal@sanofi.com">
                    Franck;VIGNAL
                                            <ExtLink title="ROR" URI="https://ror.org/02n6c9837" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="395030844" role="organisation id"/>
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      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
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    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    internal medicine</keyword>
      <keyword vocab="" vocabURI="">
                    FRAX index</keyword>
      <keyword vocab="" vocabURI="">
                    fracture risk estimate</keyword>
      <topcClas vocab="health theme">
                        Rheumatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D012219"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Internal medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/0d45044a-74d5-4bd7-b920-b92af3388576"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/f0844378-9f30-4873-b19b-5bff8c184a36"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D007388"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Fracture of unspecified body region                                            </topcClas>
      <topcClas vocab="cim-11">
                        Osteoporosis                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Estimation via the WHO index (FRAX®) of the risk of fracture by bone fragility in French women aged 50 years and older, with osteoporosis</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2008-01-01"/>
      <collDate event="end" date="2008-12-31"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">An antecedent of osteoporotic fracture, i.e. of a fracture occurring after the age of 45 years, without major trauma; A T-score at at least one of the two sites, lumbar or femoral, ≤ -2.5 SD  ; Treated or not                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
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    <developmentActivity type="primary evaluation">
      <description>Quality of life/health perception</description>
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  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
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      <respRate>4249</respRate>
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    <stdyClas>Completed study</stdyClas>
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      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
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    <relMat>Access on specific project only</relMat>
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