<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02234414</url>
  </required_header>
  <id_info>
    <org_study_id>IGO-SwOF 01</org_study_id>
    <nct_id>NCT02234414</nct_id>
  </id_info>
  <brief_title>Epidemiology, Identification Rate and Treatment Penetration of Osteoporotic Vertebral Fractures in Switzerland</brief_title>
  <acronym>SwOF</acronym>
  <official_title>Pilot Study on the Epidemiology, Identification Rate and Treatment Penetration of Vertebral Fractures Due to Osteoporosis in Switzerland (SwOF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. med. Kurt Lippuner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Interessengemeinschaft Osteoporose</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown&#xD;
      and the published data from the Swiss hospitals statistics represent only the tip of the&#xD;
      iceberg. In addition, the percentages of women correctly identified with vertebral fractures&#xD;
      due to osteoporosis and the treatment rate of these women with a drug proven to reduce the&#xD;
      risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of&#xD;
      vertebral fractures differs between urban and rural areas or between mountain areas and plain&#xD;
      country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in&#xD;
      physical activity and/ or dietary habits.&#xD;
&#xD;
      Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either&#xD;
      sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a&#xD;
      combination of both would improve sensitivity and specificity is unknown.&#xD;
&#xD;
      The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and&#xD;
      lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a&#xD;
      retrospective study of hospitalized elderly patients has shown that as many as 50% of the&#xD;
      radiographic reports failed to note the presence of moderate to severe vertebral fractures.&#xD;
      In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or&#xD;
      vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment&#xD;
      was offered to only 36% of the diagnosed patients.&#xD;
&#xD;
      The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA&#xD;
      measurements allows for the detection of vertebral deformities, which is critical for&#xD;
      management of osteoporosis, as the existence of such deformities substantially increases the&#xD;
      risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of&#xD;
      a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to&#xD;
      expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between&#xD;
      90-94%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Examinations&#xD;
&#xD;
        -  Community-dwelling women from a random sample (address lists may be chosen from public&#xD;
           and/ or private providers)&#xD;
&#xD;
        -  Aged 65-79 yrs&#xD;
&#xD;
        -  Written informed consent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2009</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">September 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years</measure>
    <time_frame>at the only study visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity, sensitivity, positive predictive value and negative predictive value for the prediction of underlying vertebral fracture of selected risk factors, clinical signs and vitamin D level, alone or in combination</measure>
    <time_frame>at the only study visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the percentage of women correctly identified with a vertebral fracture and adequately treated for underlying osteoporosis and</measure>
    <time_frame>at the only study visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the differences between these women and those who are either not correctly diagnosed or not correctly treated</measure>
    <time_frame>at the only study visit</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">303</enrollment>
  <condition>Postmenopausal Osteoporosis</condition>
  <condition>Spinal Fractures</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be based on a representative (age categories, urban vs. rural,&#xD;
        plain vs. mountain) stratified random sample taken from the general population of women&#xD;
        living in urban/ suburban and country/ mountain regions (stratified for n = one third each,&#xD;
        based on city code) in the german speaking part of Switzerland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Community-dwelling women from a random sample (address lists may be chosen from public&#xD;
             and/ or private providers)&#xD;
&#xD;
          -  Aged 65-79 yrs&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent spine surgery&#xD;
&#xD;
          -  Not willing or not able to sign informed consent&#xD;
&#xD;
          -  In patients not willing or not able to participate, the reason for denial will be&#xD;
             recorded for future evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kurt Lippuner, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Interessengemeinschaft Osteoporose</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hochgebirgsklinik Davos</name>
      <address>
        <city>Davos-Wolfgang</city>
        <zip>CH-7265</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Olten</name>
      <address>
        <city>Olten</city>
        <zip>CH-4600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HFR Tafers</name>
      <address>
        <city>Tafers</city>
        <zip>CH-1712</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>June 29, 2011</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Interessengemeinschaft Osteoporose</investigator_affiliation>
    <investigator_full_name>Prof. Dr. med. Kurt Lippuner</investigator_full_name>
    <investigator_title>President</investigator_title>
  </responsible_party>
  <keyword>vertebral fracture assessment (vfa)</keyword>
  <keyword>vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02234414
org study id: IGO-SwOF 01
nct id: NCT02234414
lead sponsor: 
has dmc: No
In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown
      and the published data from the Swiss hospitals statistics represent only the tip of the
      iceberg. In addition, the percentages of women correctly identified with vertebral fractures
      due to osteoporosis and the treatment rate of these women with a drug proven to reduce the
      risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of
      vertebral fractures differs between urban and rural areas or between mountain areas and plain
      country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in
      physical activity and/ or dietary habits.

      Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either
      sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a
      combination of both would improve sensitivity and specificity is unknown.

      The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and
      lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a
      retrospective study of hospitalized elderly patients has shown that as many as 50% of the
      radiographic reports failed to note the presence of moderate to severe vertebral fractures.
      In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or
      vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment
      was offered to only 36% of the diagnosed patients.

      The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA
      measurements allows for the detection of vertebral deformities, which is critical for
      management of osteoporosis, as the existence of such deformities substantially increases the
      risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of
      a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to
      expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between
      90-94%.
Examinations

        -  Community-dwelling women from a random sample (address lists may be chosen from public
           and/ or private providers)

        -  Aged 65-79 yrs

        -  Written informed consent
observational model: Cohort
time perspective: Prospective
measure: Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years
time frame: at the only study visit
measure: Specificity, sensitivity, positive predictive value and negative predictive value for the prediction of underlying vertebral fracture of selected risk factors, clinical signs and vitamin D level, alone or in combination
time frame: at the only study visit
measure: Assessment of the percentage of women correctly identified with a vertebral fracture and adequately treated for underlying osteoporosis and
time frame: at the only study visit
measure: Assessment of the differences between these women and those who are either not correctly diagnosed or not correctly treated
time frame: at the only study visit
serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 65 Years
maximum age: 79 Years
healthy volunteers: No
last name: Kurt Lippuner, Prof. Dr.
role: Principal Investigator
affiliation: Interessengemeinschaft Osteoporose
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Interessengemeinschaft Osteoporose
investigator full name: Prof. Dr. med. Kurt Lippuner
investigator title: President
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
mesh term: Fractures, Bone
mesh term: Spinal Fractures