<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/NCT02220699</url>
  </required_header>
  <id_info>
    <org_study_id>FEA-RN-2014-1</org_study_id>
    <nct_id>NCT02220699</nct_id>
  </id_info>
  <brief_title>Screening for Osteoporosis in General Practice</brief_title>
  <official_title>Screening for Osteoporosis in General Practice. Identifying Patients With Osteoporosis in General Practice by Using the Program Data Capture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All Danish general practices have a data capture system that collects selected data from the&#xD;
      electronic patient record. These data are used for various quality assurance purposes. The&#xD;
      aim of the study is to evaluate the quality assurance system/program that identifies patients&#xD;
      having an increased risk of osteoporosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Method&#xD;
&#xD;
      General practitioners (GPs) have the Sentinel data capture program as an integrated part of&#xD;
      their medical record system. The program identifies if a patient has one or more of the&#xD;
      following risk factors registered with an ICPC code (International Classification of Primary&#xD;
      Care - 2, Wonca International Classification Committee (WICC)):&#xD;
&#xD;
      Alcohol abuse (P15), chronic obstructive pulmonary disease (COPD) (R95), hyperthyroidism&#xD;
      (T85), rheumatoid arthritis (L88), fracture (L72, L73, L74, L75 and L76 (age &gt; 50))*,&#xD;
      anorexia (P86), glomerulonephritis/ nephropathy (U88), early menopause (ages 40 to 45 and&#xD;
      X05), smoker (current/former P17), corticosteroid treatment (at least two prescriptions),&#xD;
      body mass index (BMI) (between 10-19).&#xD;
&#xD;
      *L72: radius/ulna fracture, L73: tibia/fibula fracture, L74: hand/foot fracture, L75: femur&#xD;
      fracture, L76: NEC (not elsewhere classified) fracture.&#xD;
&#xD;
      The GP can generate a list of his own patients that have an increased risk of osteoporosis&#xD;
      with name, personal identification number, age, address, eGFR (estimated glomerular&#xD;
      filtration rate), BMI, an indication of which of the above mentioned diagnoses the patient&#xD;
      has, and whether the patient had been instructed in calcium and vitamin D intake. In order to&#xD;
      generate a list, the GP must have been using ICPC coding for at least 6 months with a minimum&#xD;
      of 70% of patient contacts.&#xD;
&#xD;
      The GP can afterwards invite these high-risk individuals for a consultation focussing on&#xD;
      osteoporosis prevention.&#xD;
&#xD;
      The Study&#xD;
&#xD;
      The study has initiated in January 2014 including two general practices (Clinic A &amp; B) from&#xD;
      the Aalborg Municipality that volunteered to participate. Based on the investigators pilot&#xD;
      study the investigators aimed at clinics with approximately 200 patients at risk in each.&#xD;
&#xD;
      Clinic A (www.laegernesloejfen.dk) is located in eastern Aalborg, Denmark. Clinic B&#xD;
      (www.lægerneiskalborg.dk) is located in southwest Aalborg, Denmark.&#xD;
&#xD;
      Clinic A and B's lists of patients at an increased risk of osteoporosis is printed and&#xD;
      downloaded, along with their ICPC coded diagnoses and data.&#xD;
&#xD;
      The patients' medical records are screened for exclusion criteria. Eligible patients are&#xD;
      contacted and asked to come for a consultation regarding the risk of developing osteoporosis.&#xD;
      The patients are contacted directly if they visit the clinic anyway; otherwise they are&#xD;
      contacted by e-mail or letter.&#xD;
&#xD;
      Patients coming for a consultation are given a questionnaire regarding osteoporosis risk&#xD;
      factors in relation to lifestyle, diet, diseases predisposing osteoporosis, fall prophylaxis,&#xD;
      and medication. The questionnaire also evaluate the patient's attitude towards being offered&#xD;
      preventive examination and treatment by his/hers general practitioner. Patients wanting a&#xD;
      consultation, but not wishing to participate in the scientific study are examined and offered&#xD;
      treatment equal to the consenting patient according to national standards.&#xD;
&#xD;
      The patients then have a consultation regarding osteoporosis prevention (typically by a&#xD;
      nurse). During the consultation the patient's different risk factors are discussed and advice&#xD;
      is given regarding fall prophylaxis, diet, calcium and vitamin D. The patient's medication is&#xD;
      examined as specified by national guidelines. All patients are then offered referral to a&#xD;
      DXA-scan.&#xD;
&#xD;
      Patients that are scanned and classified as having osteoporosis are offered a new&#xD;
      consultation regarding osteoporosis treatment and blood tests for secondary osteoporosis&#xD;
      screening purposes.&#xD;
&#xD;
      Patients with osteopenia and normal bone mineral density are informed about their test result&#xD;
      and if necessary advised to have a new DXA-scan in a few years.&#xD;
&#xD;
      The study is based on the routine identification of patients at risk of osteoporosis found by&#xD;
      using the Sentinel data capture program. Intervention is not used in the study, however the&#xD;
      patients at risk are offered regular preventive examination according to their risk&#xD;
      (DXA-scan). The study analyses data based on the quality assurance work regarding&#xD;
      osteoporosis of the general practices.&#xD;
&#xD;
      Patients are informed that participation is completely voluntary and they can withdraw from&#xD;
      the study at any time and it will have no bearing on present or future treatment. All&#xD;
      participating patients give oral and written informed consent.&#xD;
&#xD;
      Patients not wanting to participate will not be part of the study and only their sex, age,&#xD;
      risk factors and reason for exclusion will be registered anonymously in order to evaluate the&#xD;
      selection of patients.&#xD;
&#xD;
      Lack of participation in the study will have no consequences on the examination and treatment&#xD;
      offered to patients at risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with osteoporosis</measure>
    <time_frame>6 weeks after visit at the GP clinic</time_frame>
    <description>Participating patients are referred to a bone mineral density measurement (DXA scan). The exact time depends on the waiting time for bone mineral density Measurements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with osteopenia</measure>
    <time_frame>6 weeks after visit at the GP clinic</time_frame>
    <description>At the time of bone mineral density measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of identifying a patient with osteoporosis</measure>
    <time_frame>2 weeks after bone mineral density measurment</time_frame>
    <description>The total cost from inviting the patients until the patients have finished all examinations, except blood testing for secondary osteoporosis (but not including expenses after treatment for osteoporosis may have begun)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patients satisfaction with being contacted to participate in a osteoporosis prevention study</measure>
    <time_frame>baseline</time_frame>
    <description>Assessed by questionnaire</description>
  </other_outcome>
  <enrollment type="Actual">367</enrollment>
  <condition>Osteoporosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at list at the participating general pracitices who are identified to be at an&#xD;
        increased risk of osteoporosis by the data capture program are invited to participate (by&#xD;
        direct contact, mail or e-mail)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient identified as being at an increased risk of osteoporosis by the data capture&#xD;
             system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known osteoporosis.&#xD;
&#xD;
          -  Patients treated with alendronate.&#xD;
&#xD;
          -  Patients below 25 years of age.&#xD;
&#xD;
          -  Bone metastasis.&#xD;
&#xD;
          -  Terminal disease.&#xD;
&#xD;
          -  Severe dementia or other disease or condition that is incompatible with participation.&#xD;
&#xD;
          -  Bone mineral density scan within the past 3 years.&#xD;
&#xD;
          -  Errors in their ICPC coding that leads to the patient being misclassified as having an&#xD;
             increased risk of osteoporosis.&#xD;
&#xD;
          -  Patients not wanting to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lægerne Sløjfen (a family medicine clinic)</name>
      <address>
        <city>Aalborg</city>
        <state>North Denmark Region</state>
        <zip>9220</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>July 18, 2016</last_update_submitted>
  <last_update_submitted_qc>July 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Martin Bach Jensen</investigator_full_name>
    <investigator_title>GP, Ph.D, Professor at Department of Clinical Medicin, Aalborg University and head of the Research Unit of General Practice in Aalborg</investigator_title>
  </responsible_party>
  <keyword>Ostoporosis</keyword>
  <keyword>Primary Prevention</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>General Practice</keyword>
  <keyword>Secondary screening</keyword>
  <keyword>Patients at increased risk of osteoporosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02220699
org study id: FEA-RN-2014-1
nct id: NCT02220699
lead sponsor: 
collaborator: 
has dmc: No
All Danish general practices have a data capture system that collects selected data from the
      electronic patient record. These data are used for various quality assurance purposes. The
      aim of the study is to evaluate the quality assurance system/program that identifies patients
      having an increased risk of osteoporosis.
Background/Method

      General practitioners (GPs) have the Sentinel data capture program as an integrated part of
      their medical record system. The program identifies if a patient has one or more of the
      following risk factors registered with an ICPC code (International Classification of Primary
      Care - 2, Wonca International Classification Committee (WICC)):

      Alcohol abuse (P15), chronic obstructive pulmonary disease (COPD) (R95), hyperthyroidism
      (T85), rheumatoid arthritis (L88), fracture (L72, L73, L74, L75 and L76 (age > 50))*,
      anorexia (P86), glomerulonephritis/ nephropathy (U88), early menopause (ages 40 to 45 and
      X05), smoker (current/former P17), corticosteroid treatment (at least two prescriptions),
      body mass index (BMI) (between 10-19).

      *L72: radius/ulna fracture, L73: tibia/fibula fracture, L74: hand/foot fracture, L75: femur
      fracture, L76: NEC (not elsewhere classified) fracture.

      The GP can generate a list of his own patients that have an increased risk of osteoporosis
      with name, personal identification number, age, address, eGFR (estimated glomerular
      filtration rate), BMI, an indication of which of the above mentioned diagnoses the patient
      has, and whether the patient had been instructed in calcium and vitamin D intake. In order to
      generate a list, the GP must have been using ICPC coding for at least 6 months with a minimum
      of 70% of patient contacts.

      The GP can afterwards invite these high-risk individuals for a consultation focussing on
      osteoporosis prevention.

      The Study

      The study has initiated in January 2014 including two general practices (Clinic A & B) from
      the Aalborg Municipality that volunteered to participate. Based on the investigators pilot
      study the investigators aimed at clinics with approximately 200 patients at risk in each.

      Clinic A (www.laegernesloejfen.dk) is located in eastern Aalborg, Denmark. Clinic B
      (www.lægerneiskalborg.dk) is located in southwest Aalborg, Denmark.

      Clinic A and B's lists of patients at an increased risk of osteoporosis is printed and
      downloaded, along with their ICPC coded diagnoses and data.

      The patients' medical records are screened for exclusion criteria. Eligible patients are
      contacted and asked to come for a consultation regarding the risk of developing osteoporosis.
      The patients are contacted directly if they visit the clinic anyway; otherwise they are
      contacted by e-mail or letter.

      Patients coming for a consultation are given a questionnaire regarding osteoporosis risk
      factors in relation to lifestyle, diet, diseases predisposing osteoporosis, fall prophylaxis,
      and medication. The questionnaire also evaluate the patient's attitude towards being offered
      preventive examination and treatment by his/hers general practitioner. Patients wanting a
      consultation, but not wishing to participate in the scientific study are examined and offered
      treatment equal to the consenting patient according to national standards.

      The patients then have a consultation regarding osteoporosis prevention (typically by a
      nurse). During the consultation the patient's different risk factors are discussed and advice
      is given regarding fall prophylaxis, diet, calcium and vitamin D. The patient's medication is
      examined as specified by national guidelines. All patients are then offered referral to a
      DXA-scan.

      Patients that are scanned and classified as having osteoporosis are offered a new
      consultation regarding osteoporosis treatment and blood tests for secondary osteoporosis
      screening purposes.

      Patients with osteopenia and normal bone mineral density are informed about their test result
      and if necessary advised to have a new DXA-scan in a few years.

      The study is based on the routine identification of patients at risk of osteoporosis found by
      using the Sentinel data capture program. Intervention is not used in the study, however the
      patients at risk are offered regular preventive examination according to their risk
      (DXA-scan). The study analyses data based on the quality assurance work regarding
      osteoporosis of the general practices.

      Patients are informed that participation is completely voluntary and they can withdraw from
      the study at any time and it will have no bearing on present or future treatment. All
      participating patients give oral and written informed consent.

      Patients not wanting to participate will not be part of the study and only their sex, age,
      risk factors and reason for exclusion will be registered anonymously in order to evaluate the
      selection of patients.

      Lack of participation in the study will have no consequences on the examination and treatment
      offered to patients at risk.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Number of patients with osteoporosis
time frame: 6 weeks after visit at the GP clinic
description: Participating patients are referred to a bone mineral density measurement (DXA scan). The exact time depends on the waiting time for bone mineral density Measurements.
measure: Number of patients with osteopenia
time frame: 6 weeks after visit at the GP clinic
description: At the time of bone mineral density measurement
measure: Cost of identifying a patient with osteoporosis
time frame: 2 weeks after bone mineral density measurment
description: The total cost from inviting the patients until the patients have finished all examinations, except blood testing for secondary osteoporosis (but not including expenses after treatment for osteoporosis may have begun)
measure: Patients satisfaction with being contacted to participate in a osteoporosis prevention study
time frame: baseline
description: Assessed by questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Martin Bach Jensen
investigator title: GP, Ph.D, Professor at Department of Clinical Medicin, Aalborg University and head of the Research Unit of General Practice in Aalborg
mesh term: Osteoporosis
sharing ipd: No