<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF79-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>A European prospective observational study to evaluate fracture outcomes, back pain, health-related quality of life, and compliance in patients with osteoporosis during and after treatment with Forsteo®</titl>
      <IDNo>FRESH-PEF79-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="" role=""></producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                A European prospective observational study to evaluate fracture outcomes, back pain, health-related quality of life, and compliance in patients with osteoporosis during and after treatment with Forsteo®            </titl>
      <altTitl>
                    EXFOS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF79-en            </IDNo>
      <IDNo agency="PEF">
                    79                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF79                </IDNo>
    </titlStmt>
    <rspStmt>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            LILLY FRANCE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </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="">
                    Osteoporotic patients</keyword>
      <keyword vocab="" vocabURI="">
                    teriparatide</keyword>
      <keyword vocab="" vocabURI="">
                    duration of treatment</keyword>
      <keyword vocab="" vocabURI="">
                    conditions of use</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 determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Primary objective: determine the incidence of clinical vertebral fractures and non-vertebral fragility fractures in patients treated with teriparatide for about 18 months and a post-treatment follow-up period of at least 18 months. Secondary objectives: observance, treatment switching and cessation, clinical evolution, occurrence of back pain, direct costs linked to fractures.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2006-01-01"/>
      <collDate event="end" date="2012-01-01"/>
      <nation abbr="hr">
                    Croatia
                                            <concept vocab="ISO" vocabURI="hr"/>
                                    </nation>
      <nation abbr="dk">
                    Denmark
                                            <concept vocab="ISO" vocabURI="dk"/>
                                    </nation>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <nation abbr="gr">
                    Greece
                                            <concept vocab="ISO" vocabURI="gr"/>
                                    </nation>
      <nation abbr="it">
                    Italy
                                            <concept vocab="ISO" vocabURI="it"/>
                                    </nation>
      <nation abbr="no">
                    Norway
                                            <concept vocab="ISO" vocabURI="no"/>
                                    </nation>
      <nation abbr="si">
                    Slovenia
                                            <concept vocab="ISO" vocabURI="si"/>
                                    </nation>
      <nation abbr="se">
                    Sweden
                                            <concept vocab="ISO" vocabURI="se"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </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 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">Osteoporotic patients initiating treatment with teriparatide according to the practitioner's opinion in routine care                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <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>
    <anlyInfo>
      <respRate>1607</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
