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<docDscr>
  <citation>
    <titlStmt>
      <titl>Characterisation of Age-Related Bone Loss In Women</titl>
      <IDNo>FRESH-PEF60069-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Roland CHAPURLAT</producer>
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      <version></version>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Characterisation of Age-Related Bone Loss In Women            </titl>
      <altTitl>
                    OFELY                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60069-en            </IDNo>
      <IDNo agency="PEF">
                    60069                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60069                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Pierre DELMAS                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
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                                    </othId>
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    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AMGEN                    
                                    </fundAg>
      <fundAg>
                                            MSD FRANCE                    
                                    </fundAg>
      <fundAg>
                                            PREVENTION DES MALADIES OSSEUSES (PMO)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="pierre.delmas@inserm.fr">
                    Pierre;DELMAS
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    osteoporosis</keyword>
      <keyword vocab="" vocabURI="">
                    clinical risk factors</keyword>
      <keyword vocab="" vocabURI="">
                    falls</keyword>
      <keyword vocab="" vocabURI="">
                    activity</keyword>
      <keyword vocab="" vocabURI="">
                    physical</keyword>
      <keyword vocab="" vocabURI="">
                    muscular strength</keyword>
      <keyword vocab="" vocabURI="">
                    menopausal status</keyword>
      <keyword vocab="" vocabURI="">
                    anthropometric</keyword>
      <keyword vocab="" vocabURI="">
                    family history</keyword>
      <keyword vocab="" vocabURI="">
                    osteoarthritis</keyword>
      <keyword vocab="" vocabURI="">
                    Health episodes</keyword>
      <keyword vocab="" vocabURI="">
                    fractures</keyword>
      <keyword vocab="" vocabURI="">
                    treatment</keyword>
      <topcClas vocab="health theme">
                        Endocrinology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D004704"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Geriatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d37e4d8c-a978-40c7-ba4f-eee841851073"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D005853"/>
                                                </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants: Climate                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: Prospective evaluation characterising age-related bone loss normal women at different skeletal sites. Secondary objectives are: - to identify the clinical, biochemical and hormonal determinants of bone loss and to predict the rate of bone loss using biochemical markers. To investigate fracture determinants in menopausal women (bone loss, clinical, biochemical and hormonal factors as well as bone microarchitecture) - to study osteoarthritis: the relationship between osteoarthritis and osteoporosis, osteoarthritis and specific cartilage markers and longitudinal osteoarthritic development in the knees for the entire cohort</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1992-01-01"/>
      <collDate event="end" date="2009-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Auvergne Rhône-Alpes</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General 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">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </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 clusion="I">Women between 30 and 90 years old, registered with the MGEN section in Rhône, living in Rhône and the surrounding départements.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Population database for statistical purposes</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>1207</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Data may be used by academic teams Data may be used by industrial teams</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
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