<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/NCT03798444</url>
  </required_header>
  <id_info>
    <org_study_id>CRong</org_study_id>
    <nct_id>NCT03798444</nct_id>
  </id_info>
  <brief_title>Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women</brief_title>
  <official_title>An Observational and Cross-sectional Study on Prevalence of Vertebral Fractures in Postmenopausal Women Living in Chinese Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central South University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational and cross-sectional study on the height loss, kyphosis indicators,&#xD;
      bone mineral density and vertebral fractures in Chinese postmenopausal women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postmenopausal women (N=255) aged ≥50 years were randomly selected from community centers in&#xD;
      Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence&#xD;
      of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good&#xD;
      health.The criteria for exclusion were morphological abnormalities or skeletal distortions&#xD;
      that prohibited either clinical measurements or morphometric assessments of skeletal&#xD;
      radiographs All participants were interviewed using a standard questionnaire. Body weight and&#xD;
      height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing&#xD;
      light clothing and no shoes. Current height was measured using a wall-mounted stadiometer,&#xD;
      with a horizontal plate pressed on the head, and hair flattened. All subjects provided basic&#xD;
      information, including current age, age at the start of menopause, years since menopause&#xD;
      (YSM), weight, and their tallest recalled height. The current measured height subtracted from&#xD;
      the tallest recalled height was subjects' HHL.The RPD, which was the vertical distance&#xD;
      between the lowest margin of the ribs and the superior surface of the iliac crest along the&#xD;
      mid-axillary line, was measured twice by a physician who stood behind the subject. For the&#xD;
      kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and&#xD;
      back to the wall, and head in a horizontal position with a double chin shown. The&#xD;
      wall-occiput distance was defined as the horizontal distance between the wall and the back of&#xD;
      the head. The distance between the prominence of the 7th cervical vertebra and the wall was&#xD;
      defined as 7th cervical vertebra-wall distance (C7WD) , and wall-tragus-distance (WTD) was&#xD;
      defined as the horizontal distance from the participant's tragus to the wall . All RPD and&#xD;
      anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained&#xD;
      physicians.BMD of the lumbar spine, left femoral neck, and total hip were measured using dual&#xD;
      energy X-ray absorptiometry. VFs were assessed using lateral spine imaging from T4 to L4 on&#xD;
      X-ray.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Height</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. Height were measured to the closest 0.5 cm,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>4 weeks</time_frame>
    <description>Body weight was measured with subjects wearing light clothing and no shoes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rib to pelvis distance</measure>
    <time_frame>4 weeks</time_frame>
    <description>The rib to pelvis distance, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. Measured in increments of 0.1 cm by two trained physicians.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wall-occiput distance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. Measured in increments of 0.1 cm by two trained physicians.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>7th cervical vertebra-wall distance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance. Measured in increments of 0.1 cm by two trained physicians.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wall-tragus-distance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown.Wall-tragus-distance was defined as the horizontal distance from the participant's tragus to the wall. Measured in increments of 0.1 cm by two trained physicians.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Historical height loss</measure>
    <time_frame>4 weeks</time_frame>
    <description>The current measured height subtracted from the tallest recalled height was subjects' historical height loss</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">255</enrollment>
  <condition>Osteoporosis Fracture</condition>
  <arm_group>
    <arm_group_label>Bone mineral denstiy</arm_group_label>
    <description>BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry in all subjects.Accroding to The World Health Organization, we defined osteoporosis as a T-score ≤-2.5,and the non osteoporosis as T-score&gt;-2.5.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vertebral fractures</arm_group_label>
    <description>VFs were assessed using lateral spine imaging from T4 to L4 on X-ray. A visual semi-quantitative method was used, with fractures defined as a vertebral height ratio &lt;0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>dual energy X-ray absorptiometry</intervention_name>
    <description>BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. The lumbar spine, left femoral neck, or total hip of T-score ≤-2.5 as the osteoporosis</description>
    <arm_group_label>Bone mineral denstiy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>lateral spine imaging from T4 to L4 on X-ray</intervention_name>
    <description>VFs were assessed using lateral spine imaging from T4 to L4 on X-ray .A visual semi-quantitative method was used, with fractures defined as a vertebral Vertebral fractures should be diagnose if height ratio &lt;0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra</description>
    <arm_group_label>Vertebral fractures</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Postmenopausal women aged ≥50 years were randomly selected from community centers in&#xD;
        Changsha City, Hunan Province, China in September 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual&#xD;
        cycles for at least one year)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Morphological abnormalities or skeletal distortions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sheng zhifeng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central south of university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The 2nd Xiangya Hospital, Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Yoh K, Kuwabara A, Tanaka K. Detective value of historical height loss and current height/knee height ratio for prevalent vertebral fracture in Japanese postmenopausal women. J Bone Miner Metab. 2014 Sep;32(5):533-8. doi: 10.1007/s00774-013-0525-y.</citation>
    <PMID>24122280</PMID>
  </reference>
  <reference>
    <citation>Siminoski K, Warshawski RS, Jen H, Lee K. The accuracy of historical height loss for the detection of vertebral fractures in postmenopausal women. Osteoporos Int. 2006 Feb;17(2):290-6. doi: 10.1007/s00198-005-2017-y. Epub 2005 Sep 6.</citation>
    <PMID>16143833</PMID>
  </reference>
  <reference>
    <citation>Siminoski K, Warshawski RS, Jen H, Lee KC. Accuracy of physical examination using the rib-pelvis distance for detection of lumbar vertebral fractures. Am J Med. 2003 Aug 15;115(3):233-6. doi: 10.1016/s0002-9343(03)00299-7. No abstract available.</citation>
    <PMID>12935830</PMID>
  </reference>
  <reference>
    <citation>Mizukami S, Abe Y, Tsujimoto R, Arima K, Kanagae M, Chiba G, Aoyagi K. Accuracy of spinal curvature assessed by a computer-assisted device and anthropometric indicators in discriminating vertebral fractures among individuals with back pain. Osteoporos Int. 2014 Jun;25(6):1727-34. doi: 10.1007/s00198-014-2680-y. Epub 2014 Mar 14.</citation>
    <PMID>24627138</PMID>
  </reference>
  <reference>
    <citation>Suwannarat P, Amatachaya P, Sooknuan T, Tochaeng P, Kramkrathok K, Thaweewannakij T, Manimmanakorn N, Amatachaya S. Hyperkyphotic measures using distance from the wall: validity, reliability, and distance from the wall to indicate the risk for thoracic hyperkyphosis and vertebral fracture. Arch Osteoporos. 2018 Mar 12;13(1):25. doi: 10.1007/s11657-018-0433-9.</citation>
    <PMID>29532182</PMID>
  </reference>
  <reference>
    <citation>Ralston SH, Urquhart GD, Brzeski M, Sturrock RD. Prevalence of vertebral compression fractures due to osteoporosis in ankylosing spondylitis. BMJ. 1990 Mar 3;300(6724):563-5. doi: 10.1136/bmj.300.6724.563.</citation>
    <PMID>2108749</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central South University</investigator_affiliation>
    <investigator_full_name>ChenRong</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Height loss, Kyphosis</keyword>
  <keyword>Osteoporosis, Vertebral fracture</keyword>
  <keyword>Postmenopausal women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
    <mesh_term>Osteoporotic Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03798444/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03798444
org study id: CRong
nct id: NCT03798444
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is an observational and cross-sectional study on the height loss, kyphosis indicators,
      bone mineral density and vertebral fractures in Chinese postmenopausal women
Postmenopausal women (N=255) aged ≥50 years were randomly selected from community centers in
      Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence
      of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good
      health.The criteria for exclusion were morphological abnormalities or skeletal distortions
      that prohibited either clinical measurements or morphometric assessments of skeletal
      radiographs All participants were interviewed using a standard questionnaire. Body weight and
      height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing
      light clothing and no shoes. Current height was measured using a wall-mounted stadiometer,
      with a horizontal plate pressed on the head, and hair flattened. All subjects provided basic
      information, including current age, age at the start of menopause, years since menopause
      (YSM), weight, and their tallest recalled height. The current measured height subtracted from
      the tallest recalled height was subjects' HHL.The RPD, which was the vertical distance
      between the lowest margin of the ribs and the superior surface of the iliac crest along the
      mid-axillary line, was measured twice by a physician who stood behind the subject. For the
      kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and
      back to the wall, and head in a horizontal position with a double chin shown. The
      wall-occiput distance was defined as the horizontal distance between the wall and the back of
      the head. The distance between the prominence of the 7th cervical vertebra and the wall was
      defined as 7th cervical vertebra-wall distance (C7WD) , and wall-tragus-distance (WTD) was
      defined as the horizontal distance from the participant's tragus to the wall . All RPD and
      anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained
      physicians.BMD of the lumbar spine, left femoral neck, and total hip were measured using dual
      energy X-ray absorptiometry. VFs were assessed using lateral spine imaging from T4 to L4 on
      X-ray.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Height
time frame: 4 weeks
description: Subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. Height were measured to the closest 0.5 cm,
measure: Weight
time frame: 4 weeks
description: Body weight was measured with subjects wearing light clothing and no shoes
measure: Rib to pelvis distance
time frame: 4 weeks
description: The rib to pelvis distance, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. Measured in increments of 0.1 cm by two trained physicians.
measure: Wall-occiput distance
time frame: 4 weeks
description: Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. Measured in increments of 0.1 cm by two trained physicians.
measure: 7th cervical vertebra-wall distance
time frame: 4 weeks
description: Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance. Measured in increments of 0.1 cm by two trained physicians.
measure: Wall-tragus-distance
time frame: 4 weeks
description: Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown.Wall-tragus-distance was defined as the horizontal distance from the participant's tragus to the wall. Measured in increments of 0.1 cm by two trained physicians.
measure: Historical height loss
time frame: 4 weeks
description: The current measured height subtracted from the tallest recalled height was subjects' historical height loss
arm group label: Bone mineral denstiy
description: BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry in all subjects.Accroding to The World Health Organization, we defined osteoporosis as a T-score ≤-2.5,and the non osteoporosis as T-score>-2.5.
arm group label: Vertebral fractures
description: VFs were assessed using lateral spine imaging from T4 to L4 on X-ray. A visual semi-quantitative method was used, with fractures defined as a vertebral height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra.
intervention type: Radiation
intervention name: dual energy X-ray absorptiometry
description: BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. The lumbar spine, left femoral neck, or total hip of T-score ≤-2.5 as the osteoporosis
arm group label: Bone mineral denstiy
intervention type: Radiation
intervention name: lateral spine imaging from T4 to L4 on X-ray
description: VFs were assessed using lateral spine imaging from T4 to L4 on X-ray .A visual semi-quantitative method was used, with fractures defined as a vertebral Vertebral fractures should be diagnose if height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra
arm group label: Vertebral fractures
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: sheng zhifeng, MD
role: Principal Investigator
affiliation: Central south of university
facility: 
country: China
citation: Yoh K, Kuwabara A, Tanaka K. Detective value of historical height loss and current height/knee height ratio for prevalent vertebral fracture in Japanese postmenopausal women. J Bone Miner Metab. 2014 Sep;32(5):533-8. doi: 10.1007/s00774-013-0525-y.
PMID: 24122280
citation: Siminoski K, Warshawski RS, Jen H, Lee K. The accuracy of historical height loss for the detection of vertebral fractures in postmenopausal women. Osteoporos Int. 2006 Feb;17(2):290-6. doi: 10.1007/s00198-005-2017-y. Epub 2005 Sep 6.
PMID: 16143833
citation: Siminoski K, Warshawski RS, Jen H, Lee KC. Accuracy of physical examination using the rib-pelvis distance for detection of lumbar vertebral fractures. Am J Med. 2003 Aug 15;115(3):233-6. doi: 10.1016/s0002-9343(03)00299-7. No abstract available.
PMID: 12935830
citation: Mizukami S, Abe Y, Tsujimoto R, Arima K, Kanagae M, Chiba G, Aoyagi K. Accuracy of spinal curvature assessed by a computer-assisted device and anthropometric indicators in discriminating vertebral fractures among individuals with back pain. Osteoporos Int. 2014 Jun;25(6):1727-34. doi: 10.1007/s00198-014-2680-y. Epub 2014 Mar 14.
PMID: 24627138
citation: Suwannarat P, Amatachaya P, Sooknuan T, Tochaeng P, Kramkrathok K, Thaweewannakij T, Manimmanakorn N, Amatachaya S. Hyperkyphotic measures using distance from the wall: validity, reliability, and distance from the wall to indicate the risk for thoracic hyperkyphosis and vertebral fracture. Arch Osteoporos. 2018 Mar 12;13(1):25. doi: 10.1007/s11657-018-0433-9.
PMID: 29532182
citation: Ralston SH, Urquhart GD, Brzeski M, Sturrock RD. Prevalence of vertebral compression fractures due to osteoporosis in ankylosing spondylitis. BMJ. 1990 Mar 3;300(6724):563-5. doi: 10.1136/bmj.300.6724.563.
PMID: 2108749
responsible party type: Principal Investigator
investigator affiliation: Central South University
investigator full name: ChenRong
investigator title: Principal Investigator
mesh term: Osteoporosis
mesh term: Fractures, Bone
mesh term: Spinal Fractures
mesh term: Osteoporotic Fractures
sharing ipd: Undecided
provided document: 