<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/NCT03304743</url>
  </required_header>
  <id_info>
    <org_study_id>P-001</org_study_id>
    <nct_id>NCT03304743</nct_id>
  </id_info>
  <brief_title>Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis</brief_title>
  <acronym>OsteoPano</acronym>
  <official_title>Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Parma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteoporosis is a common disease that makes the bones fragile and easy to break. Osteoporotic&#xD;
      fractures are a serious health problem resulting in pain, reduced mobility, increasing degree&#xD;
      of dependence and sometimes death.&#xD;
&#xD;
      Osteoporosis is currently diagnosed by measuring bone density at the hip/spine through an&#xD;
      exam called DXA. Although all post-menopausal women are at higher risk, currently Italian&#xD;
      national guidelines do not recommend population-screening programs. This leads to several&#xD;
      cases not being identified before a fracture occurs.&#xD;
&#xD;
      Since dental panoramic radiographs (OPGs) are common procedures during dental check-ups or&#xD;
      before dental treatments, it would be of great value if dentists could use them to identify&#xD;
      people with unknown osteoporosis and early refer them to a specialist before they fracture.&#xD;
&#xD;
      While several studies support the use of panoramic indices, they have never been tested in an&#xD;
      Italian University Hospital setting and in a study adequately powered and controlled for&#xD;
      confounding variables.&#xD;
&#xD;
      The aim of this study is to assess the feasibility of using dental panoramic indices to&#xD;
      screen for post-menopausal osteoporosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      The World Health Organization (WHO) has defined osteoporosis as a level of bone mineral&#xD;
      density (BMD), calculated with DXA (Dual-energy X-ray absorptiometry) technique, 2.5 standard&#xD;
      deviations (SD) or more below the average mean value of young healthy women (T-score ≤ -2.5)&#xD;
      (Kanis et al., 2013).&#xD;
&#xD;
      Although the WHO reports that there is indirect evidence supporting screening programs in&#xD;
      women aged 65 or older, current Italian national guidelines do not recommend&#xD;
      population-screening programs for osteoporosis (SIOMMMS 2015). As a consequence, a&#xD;
      significant part of Italian osteoporotic patients that may develop a fracture is left&#xD;
      undetected and untreated. Although it is recommended to assess risk of osteoporotic fractures&#xD;
      with the WHO FRAX tool in all women ≥65 years and men ≥75 years and refer for DXA&#xD;
      accordingly, it is not clear how well this tool has been adopted by general practitioners&#xD;
      (GPs) in Italy.&#xD;
&#xD;
      Considering the high percentage of people attending regular dental visits (&gt; 22 million&#xD;
      according to ISTAT 2013) and the fact that panoramic radiographs of the jawbones are a common&#xD;
      procedure that is performed during routine dental check-ups or before several dental&#xD;
      treatments, it could be of great clinical value if dentists could opportunistically use&#xD;
      panoramic X-rays to identify patients at a high risk of osteoporosis.&#xD;
&#xD;
      In the past years, specific quantitative and qualitative indices/parameters, which can be&#xD;
      calculated on dental panoramic radiographs, have been proposed as tools to detect&#xD;
      osteoporosis, with different levels of accuracy.&#xD;
&#xD;
      Amongst the quantitative indices, the most adopted ones are the mandibular cortical width&#xD;
      (MCW) and the panoramic mandibular index (PMI). The MCW represents the width of the&#xD;
      mandibular cortex and it is measured in the mental foramen region, along a line passing&#xD;
      through the middle of the mental foramen and perpendicular to the tangent to the lower border&#xD;
      of the mandible. The PMI represents the ratio between the mandibular cortical width at mental&#xD;
      foramen region and the distance from the lower border to the inferior edge of the mental&#xD;
      foramen.&#xD;
&#xD;
      Amongst the qualitative indices, the Klemetti index (KI) is by far the most applied one. KI&#xD;
      qualitatively classifies the mandibular cortex distally to the mental foramen in the&#xD;
      following categories: C1, when the endosteal margin is even and sharp; C2, when the endosteal&#xD;
      margin presents lacunar resorption or cortical residues on one or both sides; and C3, when&#xD;
      the cortical layer is clearly porous, with heavy endosteal cortical residues. A recent&#xD;
      systematic review and meta-analysis from our group showed that the presence of any kind of&#xD;
      cortical porosity (C2+C3) is associated to a sensitivity and specificity in detecting&#xD;
      osteoporosis of 80.6% and 64.3%, respectively. The advantage of using this index, compared to&#xD;
      other available indices, is that it is straightforward and relatively easy to measure and it&#xD;
      does not require specific softwares.&#xD;
&#xD;
      It is clear that the panoramic indices cannot replace the diagnosis of osteoporosis by BMD&#xD;
      measurement with DXA scan. However, whenever a panoramic radiograph is available, they might&#xD;
      be opportunistically used to detect previously undiagnosed osteoporotic patients and refer&#xD;
      them to a specialist before they develop a fracture.&#xD;
&#xD;
      While several studies support the use of panoramic indices, they have never been tested in an&#xD;
      Italian University Hospital setting and in a study adequately powered and controlled for&#xD;
      confounding variables.&#xD;
&#xD;
      Study description:&#xD;
&#xD;
      This is cross-sectional observational study aiming to recruit a cohort of 124 consecutive&#xD;
      post-menopausal women. The only study visit will take place at the &quot;Centro Universitario di&#xD;
      Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma&quot;.&#xD;
&#xD;
      All post-menopausal women ≥ 65 years old attending the Centro Universitario di Odontoiatria&#xD;
      in the new patients' or follow-ups' clinics will be approached to check for the&#xD;
      inclusion/exclusion criteria and their willingness to take part in the study. Furthermore,&#xD;
      doctors (general practitioners or osteoporosis specialists) will be contacted and will be&#xD;
      kindly asked to inform their patient that had done a DXA scan within the past 12 months about&#xD;
      the study. Potentially eligible patients will be booked an appointment at the &quot;Centro&#xD;
      Universitario di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma&quot; to&#xD;
      check for inclusion/exclusion criteria and for the recruitment. As part of the study, they&#xD;
      will receive a full-mouth examination of the hard and soft tissues and an OPG at no cost.&#xD;
&#xD;
      Only 1 study visit will be performed.&#xD;
&#xD;
      Visit 1 (Data collection)&#xD;
&#xD;
        -  Signing of informed consent;&#xD;
&#xD;
        -  Recording of any concomitant medication;&#xD;
&#xD;
        -  Confirmation of participant eligibility in relation to the inclusion/exclusion criteria;&#xD;
&#xD;
        -  Examination of hard and soft tissues;&#xD;
&#xD;
        -  Full-mouth six-points periodontal chart, with recording of probing pocket depth (PPD),&#xD;
           recession (REC), furcation involvement and mobility.&#xD;
&#xD;
        -  Dental panoramic radiograph (OPG) if not performed at the Centro Universitario di&#xD;
           Odontoiatria within the previous 12 months&#xD;
&#xD;
      Photos of the teeth may be taken to facilitate case documentation. Subjects will not be&#xD;
      identifiable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2018</start_date>
  <completion_date type="Actual">January 7, 2021</completion_date>
  <primary_completion_date type="Actual">January 7, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>sensitivity and specificity of Klemetti Index</measure>
    <time_frame>12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement</time_frame>
    <description>To assess the sensitivity and specificity of Klemetti Index (KI) to screen for osteoporosis in postmenopausal women attending the Centre of Dentistry at the University of Parma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sensitivity and specificity of mandibular cortical width</measure>
    <time_frame>12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement</time_frame>
    <description>To assess the sensitivity and specificity of mandibular cortical width (MCW) to screen for osteoporosis in postmenopausal women</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sensitivity and specificity of panoramic mandibular index</measure>
    <time_frame>12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement</time_frame>
    <description>To assess the sensitivity and specificity of panoramic mandibular index (PMI) to screen for osteoporosis in postmenopausal women</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Precision and reproducibility of Klemetti index</measure>
    <time_frame>12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement</time_frame>
    <description>Two blind examiners will calculate the index twice (within at least one week from the first evaluation) and intra and inter examiner reproducibility will be assessed through Kappa statistics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of post-menopausal women attending a University Dental Hospital (Centro Universitario di Odontoiatria) and identified as osteoporotic with the help of the panoramic indices</measure>
    <time_frame>up to 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of osteoporotic women identified as osteoporotic with the help of panoramic indices and their risk of fractures</measure>
    <time_frame>At study completion, up to 18 months from the beginning of the study</time_frame>
    <description>this will be calculated based on the Italian modified version of FRAX, &quot;DeFRA&quot;</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">124</enrollment>
  <condition>Osteoporosis, Postmenopausal</condition>
  <arm_group>
    <arm_group_label>Post-menopausal women</arm_group_label>
    <description>A cohort of 124 consecutive post-menopausal women that performed a DXA scan within the previous 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dental panoramic radiograph</intervention_name>
    <description>If not performed within the previous 12 months at the Centre of Dentistry, an OPG will be performed during enrolment visit.&#xD;
OPGs are routine low-dose x-rays that are often performed during dental check-ups, follow-ups or before dental treatments (e.g. extractions, implant placement, etc.), as they allow the evaluation of both bone and dental structures of both jaws, the sinus and temporo-mandibular joints.</description>
    <arm_group_label>Post-menopausal women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All post-menopausal women ≥ 65 years old attending the Centro Universitario di Odontoiatria&#xD;
        in the new patients' or follow-ups' clinics will be approached to check for the&#xD;
        inclusion/exclusion criteria and their willingness to take part in the study. Furthermore,&#xD;
        doctors (general practitioners or osteoporosis specialists) will be contacted and will be&#xD;
        kindly asked to inform their patient that had done a DXA scan within the past 12 months&#xD;
        about the study. Potentially eligible patients will be booked an appointment at the &quot;Centro&#xD;
        Universitario di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma&quot;&#xD;
        to check for inclusion/exclusion criteria and for the recruitment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 65 years old&#xD;
&#xD;
          -  In self-reported menopause, defined as the permanent cessation of ovulation, for at&#xD;
             least one year (Soules et al., 2001).&#xD;
&#xD;
          -  With a DXA examination at the hip and lumbar spine performed within the previous 12&#xD;
             months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Affected by systemic diseases (with the exception of osteoporosis) recognized to&#xD;
             severely affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, diabetes&#xD;
             mellitus type 1, leukaemia, pernicious anaemia, malabsorption syndromes, chronic liver&#xD;
             disease, rheumatoid arthritis).&#xD;
&#xD;
          -  Knowingly affected by HIV or viral hepatitis.&#xD;
&#xD;
          -  History of local radiation therapy in the last five years.&#xD;
&#xD;
          -  Affected by limited mental capacity or language skills such that study information&#xD;
             cannot be understood, informed consent cannot be obtained, or simple instructions&#xD;
             cannot be followed.&#xD;
&#xD;
          -  Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality which may increase the risk associated with trial participation or may&#xD;
             interfere with the interpretation of study results and, in the judgment of the&#xD;
             investigator, would make the participant inappropriate for entry into this trial.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women in menopause</gender_description>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Calciolari, DDS, MS, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma and Queen Mary University of London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Universitario di Odontoiatria</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Calciolari E, Donos N, Park JC, Petrie A, Mardas N. Panoramic measures for oral bone mass in detecting osteoporosis: a systematic review and meta-analysis. J Dent Res. 2015 Mar;94(3 Suppl):17S-27S. doi: 10.1177/0022034514554949. Epub 2014 Nov 3.</citation>
    <PMID>25365969</PMID>
  </reference>
  <reference>
    <citation>Calciolari E, Donos N, Park JC, Petrie A, Mardas N. A systematic review on the correlation between skeletal and jawbone mineral density in osteoporotic subjects. Clin Oral Implants Res. 2016 Apr;27(4):433-42. doi: 10.1111/clr.12597. Epub 2015 Apr 12.</citation>
    <PMID>25864584</PMID>
  </reference>
  <reference>
    <citation>Klemetti E, Kolmakov S, Kroger H. Pantomography in assessment of the osteoporosis risk group. Scand J Dent Res. 1994 Feb;102(1):68-72. doi: 10.1111/j.1600-0722.1994.tb01156.x.</citation>
    <PMID>8153584</PMID>
  </reference>
  <reference>
    <citation>Benson BW, Prihoda TJ, Glass BJ. Variations in adult cortical bone mass as measured by a panoramic mandibular index. Oral Surg Oral Med Oral Pathol. 1991 Mar;71(3):349-56. doi: 10.1016/0030-4220(91)90314-3.</citation>
    <PMID>2011361</PMID>
  </reference>
  <reference>
    <citation>Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013 Jan;24(1):23-57. doi: 10.1007/s00198-012-2074-y. Epub 2012 Oct 19.</citation>
    <PMID>23079689</PMID>
  </reference>
  <reference>
    <citation>Horner K, Devlin H. The relationship between mandibular bone mineral density and panoramic radiographic measurements. J Dent. 1998 May;26(4):337-43. doi: 10.1016/s0300-5712(97)00020-1.</citation>
    <PMID>9611939</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Parma</investigator_affiliation>
    <investigator_full_name>Dr Elena Calciolari</investigator_full_name>
    <investigator_title>Dr, MS, Phd, Clinical Research Fellow</investigator_title>
  </responsible_party>
  <keyword>dental panoramic radiographs</keyword>
  <keyword>osteoporosis</keyword>
  <keyword>feasibility study</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Information with regards to study participants will be kept confidential and data will be pseudo anonymised</ipd_description>
  </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/NCT03304743
org study id: P-001
nct id: NCT03304743
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Osteoporosis is a common disease that makes the bones fragile and easy to break. Osteoporotic
      fractures are a serious health problem resulting in pain, reduced mobility, increasing degree
      of dependence and sometimes death.

      Osteoporosis is currently diagnosed by measuring bone density at the hip/spine through an
      exam called DXA. Although all post-menopausal women are at higher risk, currently Italian
      national guidelines do not recommend population-screening programs. This leads to several
      cases not being identified before a fracture occurs.

      Since dental panoramic radiographs (OPGs) are common procedures during dental check-ups or
      before dental treatments, it would be of great value if dentists could use them to identify
      people with unknown osteoporosis and early refer them to a specialist before they fracture.

      While several studies support the use of panoramic indices, they have never been tested in an
      Italian University Hospital setting and in a study adequately powered and controlled for
      confounding variables.

      The aim of this study is to assess the feasibility of using dental panoramic indices to
      screen for post-menopausal osteoporosis.
Background:

      The World Health Organization (WHO) has defined osteoporosis as a level of bone mineral
      density (BMD), calculated with DXA (Dual-energy X-ray absorptiometry) technique, 2.5 standard
      deviations (SD) or more below the average mean value of young healthy women (T-score ≤ -2.5)
      (Kanis et al., 2013).

      Although the WHO reports that there is indirect evidence supporting screening programs in
      women aged 65 or older, current Italian national guidelines do not recommend
      population-screening programs for osteoporosis (SIOMMMS 2015). As a consequence, a
      significant part of Italian osteoporotic patients that may develop a fracture is left
      undetected and untreated. Although it is recommended to assess risk of osteoporotic fractures
      with the WHO FRAX tool in all women ≥65 years and men ≥75 years and refer for DXA
      accordingly, it is not clear how well this tool has been adopted by general practitioners
      (GPs) in Italy.

      Considering the high percentage of people attending regular dental visits (> 22 million
      according to ISTAT 2013) and the fact that panoramic radiographs of the jawbones are a common
      procedure that is performed during routine dental check-ups or before several dental
      treatments, it could be of great clinical value if dentists could opportunistically use
      panoramic X-rays to identify patients at a high risk of osteoporosis.

      In the past years, specific quantitative and qualitative indices/parameters, which can be
      calculated on dental panoramic radiographs, have been proposed as tools to detect
      osteoporosis, with different levels of accuracy.

      Amongst the quantitative indices, the most adopted ones are the mandibular cortical width
      (MCW) and the panoramic mandibular index (PMI). The MCW represents the width of the
      mandibular cortex and it is measured in the mental foramen region, along a line passing
      through the middle of the mental foramen and perpendicular to the tangent to the lower border
      of the mandible. The PMI represents the ratio between the mandibular cortical width at mental
      foramen region and the distance from the lower border to the inferior edge of the mental
      foramen.

      Amongst the qualitative indices, the Klemetti index (KI) is by far the most applied one. KI
      qualitatively classifies the mandibular cortex distally to the mental foramen in the
      following categories: C1, when the endosteal margin is even and sharp; C2, when the endosteal
      margin presents lacunar resorption or cortical residues on one or both sides; and C3, when
      the cortical layer is clearly porous, with heavy endosteal cortical residues. A recent
      systematic review and meta-analysis from our group showed that the presence of any kind of
      cortical porosity (C2+C3) is associated to a sensitivity and specificity in detecting
      osteoporosis of 80.6% and 64.3%, respectively. The advantage of using this index, compared to
      other available indices, is that it is straightforward and relatively easy to measure and it
      does not require specific softwares.

      It is clear that the panoramic indices cannot replace the diagnosis of osteoporosis by BMD
      measurement with DXA scan. However, whenever a panoramic radiograph is available, they might
      be opportunistically used to detect previously undiagnosed osteoporotic patients and refer
      them to a specialist before they develop a fracture.

      While several studies support the use of panoramic indices, they have never been tested in an
      Italian University Hospital setting and in a study adequately powered and controlled for
      confounding variables.

      Study description:

      This is cross-sectional observational study aiming to recruit a cohort of 124 consecutive
      post-menopausal women. The only study visit will take place at the "Centro Universitario di
      Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma".

      All post-menopausal women ≥ 65 years old attending the Centro Universitario di Odontoiatria
      in the new patients' or follow-ups' clinics will be approached to check for the
      inclusion/exclusion criteria and their willingness to take part in the study. Furthermore,
      doctors (general practitioners or osteoporosis specialists) will be contacted and will be
      kindly asked to inform their patient that had done a DXA scan within the past 12 months about
      the study. Potentially eligible patients will be booked an appointment at the "Centro
      Universitario di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma" to
      check for inclusion/exclusion criteria and for the recruitment. As part of the study, they
      will receive a full-mouth examination of the hard and soft tissues and an OPG at no cost.

      Only 1 study visit will be performed.

      Visit 1 (Data collection)

        -  Signing of informed consent;

        -  Recording of any concomitant medication;

        -  Confirmation of participant eligibility in relation to the inclusion/exclusion criteria;

        -  Examination of hard and soft tissues;

        -  Full-mouth six-points periodontal chart, with recording of probing pocket depth (PPD),
           recession (REC), furcation involvement and mobility.

        -  Dental panoramic radiograph (OPG) if not performed at the Centro Universitario di
           Odontoiatria within the previous 12 months

      Photos of the teeth may be taken to facilitate case documentation. Subjects will not be
      identifiable.
observational model: Case-Control
time perspective: Cross-Sectional
measure: sensitivity and specificity of Klemetti Index
time frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement
description: To assess the sensitivity and specificity of Klemetti Index (KI) to screen for osteoporosis in postmenopausal women attending the Centre of Dentistry at the University of Parma
measure: sensitivity and specificity of mandibular cortical width
time frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement
description: To assess the sensitivity and specificity of mandibular cortical width (MCW) to screen for osteoporosis in postmenopausal women
measure: sensitivity and specificity of panoramic mandibular index
time frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement
description: To assess the sensitivity and specificity of panoramic mandibular index (PMI) to screen for osteoporosis in postmenopausal women
measure: Precision and reproducibility of Klemetti index
time frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement
description: Two blind examiners will calculate the index twice (within at least one week from the first evaluation) and intra and inter examiner reproducibility will be assessed through Kappa statistics
measure: Number of post-menopausal women attending a University Dental Hospital (Centro Universitario di Odontoiatria) and identified as osteoporotic with the help of the panoramic indices
time frame: up to 18 months
measure: number of osteoporotic women identified as osteoporotic with the help of panoramic indices and their risk of fractures
time frame: At study completion, up to 18 months from the beginning of the study
description: this will be calculated based on the Italian modified version of FRAX, "DeFRA"
arm group label: Post-menopausal women
description: A cohort of 124 consecutive post-menopausal women that performed a DXA scan within the previous 12 months
intervention type: Diagnostic Test
intervention name: Dental panoramic radiograph
description: If not performed within the previous 12 months at the Centre of Dentistry, an OPG will be performed during enrolment visit.
OPGs are routine low-dose x-rays that are often performed during dental check-ups, follow-ups or before dental treatments (e.g. extractions, implant placement, etc.), as they allow the evaluation of both bone and dental structures of both jaws, the sinus and temporo-mandibular joints.
arm group label: Post-menopausal women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women in menopause
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elena Calciolari, DDS, MS, PHD
role: Principal Investigator
affiliation: University of Parma and Queen Mary University of London
facility: 
country: Italy
citation: Calciolari E, Donos N, Park JC, Petrie A, Mardas N. Panoramic measures for oral bone mass in detecting osteoporosis: a systematic review and meta-analysis. J Dent Res. 2015 Mar;94(3 Suppl):17S-27S. doi: 10.1177/0022034514554949. Epub 2014 Nov 3.
PMID: 25365969
citation: Calciolari E, Donos N, Park JC, Petrie A, Mardas N. A systematic review on the correlation between skeletal and jawbone mineral density in osteoporotic subjects. Clin Oral Implants Res. 2016 Apr;27(4):433-42. doi: 10.1111/clr.12597. Epub 2015 Apr 12.
PMID: 25864584
citation: Klemetti E, Kolmakov S, Kroger H. Pantomography in assessment of the osteoporosis risk group. Scand J Dent Res. 1994 Feb;102(1):68-72. doi: 10.1111/j.1600-0722.1994.tb01156.x.
PMID: 8153584
citation: Benson BW, Prihoda TJ, Glass BJ. Variations in adult cortical bone mass as measured by a panoramic mandibular index. Oral Surg Oral Med Oral Pathol. 1991 Mar;71(3):349-56. doi: 10.1016/0030-4220(91)90314-3.
PMID: 2011361
citation: Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013 Jan;24(1):23-57. doi: 10.1007/s00198-012-2074-y. Epub 2012 Oct 19.
PMID: 23079689
citation: Horner K, Devlin H. The relationship between mandibular bone mineral density and panoramic radiographic measurements. J Dent. 1998 May;26(4):337-43. doi: 10.1016/s0300-5712(97)00020-1.
PMID: 9611939
responsible party type: Principal Investigator
investigator affiliation: University of Parma
investigator full name: Dr Elena Calciolari
investigator title: Dr, MS, Phd, Clinical Research Fellow
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
sharing ipd: No
ipd description: Information with regards to study participants will be kept confidential and data will be pseudo anonymised