<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/NCT02247011</url>
  </required_header>
  <id_info>
    <org_study_id>XWB-MISP-PKVF</org_study_id>
    <nct_id>NCT02247011</nct_id>
  </id_info>
  <brief_title>A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women</brief_title>
  <acronym>PK-VF</acronym>
  <official_title>A 5-Year Long-term Follow-up Study of a Cross-Sectional Cohort Study (PK-VF) For the Examination of the Association of Vitamin D/Bone Turnover/Bone Mineral Density With an Incident Fracture in Chinese Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposed study was designed to investigate the prevalence of a 5-year incident&#xD;
      osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D&#xD;
      (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the&#xD;
      Chinese postmenopausal women, based on an endeavor of a 5-year post-baseline follow-up visit&#xD;
      of a previous cross-sectional study, PK-VF, in which 1724 participants were enrolled and&#xD;
      examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. In 2013, 5 years after PK-VF, the same 2070 subjects were contacted by the original&#xD;
           sites. Among them 1242 subjects were able to come for the follow-up assessment.&#xD;
&#xD;
        2. Clinical assessments: The participant's bio-information, physical examination and&#xD;
           medical history were collected;Questionnaire including social/life style and medical&#xD;
           evaluations (years since menopause (YSM), fracture history, milk/yoghourt/coffee/wine&#xD;
           intake, calcium intake, or smoking history) were collected by PK-VF investigators.&#xD;
           Non-vertebral fracture history evaluation: specific non-vertebral fracture sites include&#xD;
           rib or clavicle, forearm, upper arm, hand (including wrist), pelvis, hip, thigh (not&#xD;
           including hip), leg, and foot (including ankle). When non-vertebral fractures are&#xD;
           suspected, questions were raised to the participant to eliminate possible biases (How&#xD;
           did you get these fractures, a slight fall at home, fell from a high place, hit by&#xD;
           someone, broken during a car accident or an operation? Did you see a doctor to confirm&#xD;
           these fractures?) A fracture occurred in regular daily activities or due to mild trauma&#xD;
           was defined as fragile non-vertebral fracture.&#xD;
&#xD;
        3. Biochemical measurements: Fasting blood sample (~5 ml) was collected from each&#xD;
           participant at participating sites; In 2007-2008 study, blood samples were collected&#xD;
           during April-July, while in the 5-year follow-up; samples were collected in the same&#xD;
           period of time. C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal&#xD;
           prepeptide of type I procollagen (P1NP), and 25 (OH) D will be determined by a&#xD;
           laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel,&#xD;
           Switzerland) in the institute (Peking Union); Chemistry including alkaline phosphatase&#xD;
           (ALP), calcium (Ca), creatinine (Cr), and glucose, will be measured by using automated&#xD;
           techniques in the institute (Peking Union);&#xD;
&#xD;
        4. BMD measurements: Lumbar spine (LS) and femoral neck (FN) BMDs by dual-energy x-ray&#xD;
           absorptiometry (DXA) (Lunar or Norland) at PK-VF sites. BMD calibration: The&#xD;
           participant's BMD were evaluated by the same type of DXA as previous. The coefficients&#xD;
           of variation of the seven hospitals were 0.75% to 1.7% for LS and 0.56% to 1.0% for FN.&#xD;
           Cross-calibration equations between machines are: LS BMD (g/cm^2) Lunar = 1.012 ×&#xD;
           Norland + 0.0137 and, FN BMD (g/cm^2) Lunar = 1.0377 × Norland + 0.00026&#xD;
&#xD;
        5. Vertebral fracture diagnosis: Lateral radiographs of the thoracolumbar spine (T4-L5)&#xD;
           were taken at PK-VF sites. Vertebral fractures will be assessed using Genant's&#xD;
           semi-quantitative visual criteria. Two specialist radiologists will independently&#xD;
           evaluate and diagnose vertebral fracture. A worsened existing vertebral fracture will be&#xD;
           regarded as a new vertebral fracture.&#xD;
&#xD;
      In 2007-2008 study(Published article about this study could be found in Pubmed, PMID:&#xD;
      24760246), 2070 participants were recruited in this cohort, and 837 subjects (40%) were&#xD;
      diagnosed as osteoporosis. After 5 years, 1242 subjects agreed to be re-evaluated in 2013.&#xD;
      Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained at the&#xD;
      5-year follow up. We estimate that around 625 subjects would be diagnosed as osteoporosis.&#xD;
      The remaining works include blood sample test (25(OH)D, CTX and P1NP),spine x-ray films&#xD;
      reading, data input and statistical analysis, paper writing and publication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non-vertebral Fracture Incidence</measure>
    <time_frame>5 year</time_frame>
    <description>Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertebral Fracture Incidence</measure>
    <time_frame>5 year</time_frame>
    <description>Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>5 year</time_frame>
    <description>bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone Turnover Markers and 25(OH)D</measure>
    <time_frame>5 year</time_frame>
    <description>C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biochemical Markers</measure>
    <time_frame>5 year</time_frame>
    <description>Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Alkaline Phosphatase</measure>
    <time_frame>5 years</time_frame>
    <description>Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Creatinine</measure>
    <time_frame>5 years</time_frame>
    <description>Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1100</enrollment>
  <condition>Osteoporotic Fractures</condition>
  <condition>Osteoporosis, Postmenopausal</condition>
  <arm_group>
    <arm_group_label>fracture group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-fracture group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionaire survey</intervention_name>
    <description>We used a questionnaireto collect clinical data of the subjects. The questionnaire includes basic data, menstruation and pregnancy, habits and customs, daily activity, common healthy situation, history of drugs and history of factures.</description>
    <arm_group_label>fracture group</arm_group_label>
    <arm_group_label>non-fracture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Bone mineral density examination</intervention_name>
    <description>We use dual energy X-ray absorptiometry (DXA) to exam the BMD at lumbar spine (L2-4, LS) and hip.</description>
    <arm_group_label>fracture group</arm_group_label>
    <arm_group_label>non-fracture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Vertebral fracture assessment</intervention_name>
    <description>X-ray of thoracic and lumbar spine was taken, and the pictures were read by radiological specialists. The diagnosis of vertebral fracture was executed according to Genant's semiquantitative technique.</description>
    <arm_group_label>fracture group</arm_group_label>
    <arm_group_label>non-fracture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biochemical markers analysis</intervention_name>
    <description>Fasting blood sample was collected for each subject. Common biochemical maerkers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP), alanine aminotransferase(ALT) were analyzed. Besides, we also detect bone speficific markers including 25-hydroxyl Vitamin D(25OHD), parathyroid hormone(PTH), β-isomerized C-terminal telopeptide of type I collagen(β-CTX), N-terminal procollagen of type 1 collagen(P1NP) and osteocalcin(OC).</description>
    <arm_group_label>fracture group</arm_group_label>
    <arm_group_label>non-fracture group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. postmenopausal women (normally over 50 years old and years since menopause over than 1&#xD;
             year) in Peking.&#xD;
&#xD;
          2. participants without any fracture in 2007 PK-VF study were included in the prospective&#xD;
             study investigating the association of bone turnover markers/BMD/25(OH)D with fracture&#xD;
             incidence.&#xD;
&#xD;
        Exclusion Criteria: participants with years since menopause less than 1 year.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>108 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weibo Xia, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Endocrinology, Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Endocrinology, Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <results_first_submitted>May 19, 2016</results_first_submitted>
  <results_first_submitted_qc>August 8, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 30, 2016</results_first_posted>
  <last_update_submitted>August 8, 2016</last_update_submitted>
  <last_update_submitted_qc>August 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone mineral density</keyword>
  <keyword>25(OH)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>Osteoporotic Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013.</recruitment_details>
      <pre_assignment_details>All participants who agreed to be re-evaluated were enrolled in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Subjects</title>
          <description>In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="975"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Poor quality of radiological results</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fracture Group</title>
          <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
        </group>
        <group group_id="B2">
          <title>Non-fracture Group</title>
          <description>Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="111"/>
            <count group_id="B2" value="864"/>
            <count group_id="B3" value="975"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.08" lower_limit="64.23" upper_limit="76.81"/>
                    <measurement group_id="B2" value="66.09" lower_limit="59.84" upper_limit="74.59"/>
                    <measurement group_id="B3" value="66.72" lower_limit="60.09" upper_limit="74.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="864"/>
                    <measurement group_id="B3" value="975"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years since menopause</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.36" lower_limit="12.87" upper_limit="29.59"/>
                    <measurement group_id="B2" value="16.43" lower_limit="9.52" upper_limit="24.9"/>
                    <measurement group_id="B3" value="16.92" lower_limit="9.98" upper_limit="25.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous osteoporotic fracture</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Previous osteoporotic fracture</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="288"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No previous osteoporotic fracture</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="576"/>
                    <measurement group_id="B3" value="615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.21" spread="5.04"/>
                    <measurement group_id="B2" value="25.47" spread="4.85"/>
                    <measurement group_id="B3" value="25.46" spread="4.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Non-vertebral Fracture Incidence</title>
        <description>Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).</description>
        <time_frame>5 year</time_frame>
        <population>In 1100 participants, 975 of them finished the questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Fracture Group</title>
            <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Non-fracture Group</title>
            <description>Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Non-vertebral Fracture Incidence</title>
          <description>Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).</description>
          <population>In 1100 participants, 975 of them finished the questionnaire</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vertebral Fracture Incidence</title>
        <description>Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)</description>
        <time_frame>5 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fracture Group</title>
            <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Non-fracture Group</title>
            <description>Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Vertebral Fracture Incidence</title>
          <description>Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bone Mineral Density</title>
        <description>bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)</description>
        <time_frame>5 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fracture Group</title>
            <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Non-fracture Group</title>
            <description>Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Mineral Density</title>
          <description>bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)</description>
          <units>g/cm^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lumbar spine BMD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.907" lower_limit="0.784" upper_limit="1.015"/>
                    <measurement group_id="O2" value="0.956" lower_limit="0.837" upper_limit="1.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Femoral neck BMD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.686" lower_limit="0.611" upper_limit="0.755"/>
                    <measurement group_id="O2" value="0.732" lower_limit="0.647" upper_limit="0.820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total hip BMD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.788" lower_limit="0.736" upper_limit="0.845"/>
                    <measurement group_id="O2" value="0.845" lower_limit="0.760" upper_limit="0.936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bone Turnover Markers and 25(OH)D</title>
        <description>C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)</description>
        <time_frame>5 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fracture Group</title>
            <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Non-fracture Group</title>
            <description>Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Turnover Markers and 25(OH)D</title>
          <description>C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)</description>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>β-CTX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.437" lower_limit="0.309" upper_limit="0.529"/>
                    <measurement group_id="O2" value="0.401" lower_limit="0.285" upper_limit="0.540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P1NP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.88" lower_limit="41.40" upper_limit="70.16"/>
                    <measurement group_id="O2" value="51.57" lower_limit="39.76" upper_limit="67.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25(OH)D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.21" lower_limit="10.00" upper_limit="17.43"/>
                    <measurement group_id="O2" value="12.49" lower_limit="9.25" upper_limit="16.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Biochemical Markers</title>
        <description>Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.</description>
        <time_frame>5 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fracture Group</title>
            <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Non-fracture Group</title>
            <description>Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemical Markers</title>
          <description>Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serum calcium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.302" spread="0.565"/>
                    <measurement group_id="O2" value="2.263" spread="0.625"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum phosphate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.148" spread="0.220"/>
                    <measurement group_id="O2" value="1.122" spread="0.345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum glucose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.083" spread="1.810"/>
                    <measurement group_id="O2" value="6.112" spread="1.281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Alkaline Phosphatase</title>
        <description>Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.</description>
        <time_frame>5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fracture Group</title>
            <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Non-fracture Group</title>
            <description>Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Alkaline Phosphatase</title>
          <description>Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.4" spread="33.0"/>
                    <measurement group_id="O2" value="77.5" spread="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Creatinine</title>
        <description>Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.</description>
        <time_frame>5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fracture Group</title>
            <description>Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Non-fracture Group</title>
            <description>Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Creatinine</title>
          <description>Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.</description>
          <units>umol/l</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.77" spread="17.73"/>
                    <measurement group_id="O2" value="64.91" spread="14.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Overall Subjects</title>
          <description>In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants. Of all these participants, 975 participants finished the questionnaire and for 961 of them, the spine x-ray was of enough quality to determine if there is vertebral fracture.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="975"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="975"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Weibo Xia</name_or_title>
      <organization>Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital,Chinese Academy of Medical Science</organization>
      <phone>86-10-6915-5076</phone>
      <email>xiaweibo@medmail.com.cn</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02247011
org study id: XWB-MISP-PKVF
nct id: NCT02247011
lead sponsor: 
has dmc: Yes
This proposed study was designed to investigate the prevalence of a 5-year incident
      osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D
      (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the
      Chinese postmenopausal women, based on an endeavor of a 5-year post-baseline follow-up visit
      of a previous cross-sectional study, PK-VF, in which 1724 participants were enrolled and
      examined.
1. In 2013, 5 years after PK-VF, the same 2070 subjects were contacted by the original
           sites. Among them 1242 subjects were able to come for the follow-up assessment.

        2. Clinical assessments: The participant's bio-information, physical examination and
           medical history were collected;Questionnaire including social/life style and medical
           evaluations (years since menopause (YSM), fracture history, milk/yoghourt/coffee/wine
           intake, calcium intake, or smoking history) were collected by PK-VF investigators.
           Non-vertebral fracture history evaluation: specific non-vertebral fracture sites include
           rib or clavicle, forearm, upper arm, hand (including wrist), pelvis, hip, thigh (not
           including hip), leg, and foot (including ankle). When non-vertebral fractures are
           suspected, questions were raised to the participant to eliminate possible biases (How
           did you get these fractures, a slight fall at home, fell from a high place, hit by
           someone, broken during a car accident or an operation? Did you see a doctor to confirm
           these fractures?) A fracture occurred in regular daily activities or due to mild trauma
           was defined as fragile non-vertebral fracture.

        3. Biochemical measurements: Fasting blood sample (~5 ml) was collected from each
           participant at participating sites; In 2007-2008 study, blood samples were collected
           during April-July, while in the 5-year follow-up; samples were collected in the same
           period of time. C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal
           prepeptide of type I procollagen (P1NP), and 25 (OH) D will be determined by a
           laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel,
           Switzerland) in the institute (Peking Union); Chemistry including alkaline phosphatase
           (ALP), calcium (Ca), creatinine (Cr), and glucose, will be measured by using automated
           techniques in the institute (Peking Union);

        4. BMD measurements: Lumbar spine (LS) and femoral neck (FN) BMDs by dual-energy x-ray
           absorptiometry (DXA) (Lunar or Norland) at PK-VF sites. BMD calibration: The
           participant's BMD were evaluated by the same type of DXA as previous. The coefficients
           of variation of the seven hospitals were 0.75% to 1.7% for LS and 0.56% to 1.0% for FN.
           Cross-calibration equations between machines are: LS BMD (g/cm^2) Lunar = 1.012 ×
           Norland + 0.0137 and, FN BMD (g/cm^2) Lunar = 1.0377 × Norland + 0.00026

        5. Vertebral fracture diagnosis: Lateral radiographs of the thoracolumbar spine (T4-L5)
           were taken at PK-VF sites. Vertebral fractures will be assessed using Genant's
           semi-quantitative visual criteria. Two specialist radiologists will independently
           evaluate and diagnose vertebral fracture. A worsened existing vertebral fracture will be
           regarded as a new vertebral fracture.

      In 2007-2008 study(Published article about this study could be found in Pubmed, PMID:
      24760246), 2070 participants were recruited in this cohort, and 837 subjects (40%) were
      diagnosed as osteoporosis. After 5 years, 1242 subjects agreed to be re-evaluated in 2013.
      Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained at the
      5-year follow up. We estimate that around 625 subjects would be diagnosed as osteoporosis.
      The remaining works include blood sample test (25(OH)D, CTX and P1NP),spine x-ray films
      reading, data input and statistical analysis, paper writing and publication.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Non-vertebral Fracture Incidence
time frame: 5 year
description: Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).
measure: Vertebral Fracture Incidence
time frame: 5 year
description: Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)
measure: Bone Mineral Density
time frame: 5 year
description: bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)
measure: Bone Turnover Markers and 25(OH)D
time frame: 5 year
description: C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)
measure: Biochemical Markers
time frame: 5 year
description: Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.
measure: Serum Alkaline Phosphatase
time frame: 5 years
description: Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.
measure: Serum Creatinine
time frame: 5 years
description: Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.
arm group label: fracture group
arm group type: Other
description: Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
arm group label: non-fracture group
arm group type: Other
description: Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
intervention type: Other
intervention name: Questionaire survey
description: We used a questionnaireto collect clinical data of the subjects. The questionnaire includes basic data, menstruation and pregnancy, habits and customs, daily activity, common healthy situation, history of drugs and history of factures.
arm group label: fracture group
arm group label: non-fracture group
intervention type: Radiation
intervention name: Bone mineral density examination
description: We use dual energy X-ray absorptiometry (DXA) to exam the BMD at lumbar spine (L2-4, LS) and hip.
arm group label: fracture group
arm group label: non-fracture group
intervention type: Radiation
intervention name: Vertebral fracture assessment
description: X-ray of thoracic and lumbar spine was taken, and the pictures were read by radiological specialists. The diagnosis of vertebral fracture was executed according to Genant's semiquantitative technique.
arm group label: fracture group
arm group label: non-fracture group
intervention type: Other
intervention name: Biochemical markers analysis
description: Fasting blood sample was collected for each subject. Common biochemical maerkers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP), alanine aminotransferase(ALT) were analyzed. Besides, we also detect bone speficific markers including 25-hydroxyl Vitamin D(25OHD), parathyroid hormone(PTH), β-isomerized C-terminal telopeptide of type I collagen(β-CTX), N-terminal procollagen of type 1 collagen(P1NP) and osteocalcin(OC).
arm group label: fracture group
arm group label: non-fracture group
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 108 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Weibo Xia, MD
role: Study Chair
affiliation: Department of Endocrinology, Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
mesh term: Fractures, Bone
mesh term: Osteoporotic Fractures
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 