<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/NCT02967978</url>
  </required_header>
  <id_info>
    <org_study_id>GEO-Osteo-2016</org_study_id>
    <nct_id>NCT02967978</nct_id>
  </id_info>
  <brief_title>Study on the Predictive Value of the Natural Calcium Isotope Ratio in Urine and Serum for the Diagnosis of Osteoporosis</brief_title>
  <official_title>Study on the Predictive Value of the Natural Calcium Isotope Ratio in Urine and Serum for the Diagnosis of Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Research Center Kiel GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kiel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinical Research Center Kiel GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims at investigating whether the natural calcium isotope ratio (δ44/40Ca) in urine&#xD;
      and serum differs between postmenopausal women aged 50 to 75 years suffering from&#xD;
      osteoporosis and a healthy control group and whether δ44/40Ca in urine and serum can be used&#xD;
      for the diagnosis of osteoporosis or whether further parameters have to be included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the operational definition of WHO in the year 1994 osteoporosis is present if&#xD;
      bone mineral content as assessed by DXA densitometry of the lumbar spine and/or proximal&#xD;
      femur (total area or femoral neck) deviates from the mean of a 20 to 29 years old women by at&#xD;
      least -2.5 standard deviations (DXA T-Score ≤ -2.5). This definition of osteoporosis is only&#xD;
      valid after exclusion of other disorders, which may be associated with a reduction of bone&#xD;
      mineral content and exclusion of osteomalacia.&#xD;
&#xD;
      By an individual screening 100 women will be included in the study who are characterized&#xD;
      concerning existing or non-existing osteoporosis according to the guidelines of DVO 2014 and&#xD;
      ISCD 2015, respectively.&#xD;
&#xD;
      According to the EPOS study results the prevalence of osteoporosis in Germany in&#xD;
      postmenopausal women aged 50 to 60 years is about 15% and at the age of more than 70 years&#xD;
      about 45%. In case of risk factors, such as hip fracture of father and/or mother, smoking,&#xD;
      lactose intolerance, vegan nutrition, underweight (BMI &lt; 20), diabetes, intake of loop&#xD;
      diuretics, glucocorticoids, aromatase inhibitors and proton pump inhibitors a higher&#xD;
      prevalence can be assumed. Thus by electing women with at least one risk factor of&#xD;
      osteoporosis a higher proportion may meet the criteria of osteoporosis.&#xD;
&#xD;
      Since some women are expected to present with low vitamin D levels and so far are expected to&#xD;
      present with osteomalacia, and since other exclusion criteria may occur, N = 100 women will&#xD;
      be investigated, in order to obtain data from N = 80 women who may meet the criteria of the&#xD;
      target group (about N = 40 with osteoporosis and about N = 40 without osteoporosis (normal&#xD;
      control).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2016</start_date>
  <completion_date type="Actual">August 16, 2019</completion_date>
  <primary_completion_date type="Actual">March 3, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>calcium isotope ratio δ44/40Ca in urine</measure>
    <time_frame>24 hours</time_frame>
    <description>δ44/40Ca in urine of postmenopausal women who fulfill the criteria of osteoporosis are compared with δ44/40Ca in urine of those who do not fulfill the criteria using Mann-Whitney tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the natural calcium isotope ratio δ44/40Ca in urine and serum (δ44/40Ca urine x serum)</measure>
    <time_frame>24 hours</time_frame>
    <description>Elucidating whether the natural calcium isotope ratio δ44/40Ca in urine and serum (δ44/40Caurine x serum) differ between women with and without osteoporosis. For this purpose the δ44/40Caurine x serum of women who fulfill the criteria of osteoporosis are compared with δ44/40Caurine x serum of those who do not fulfill the criteria using Mann-Whitney tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>turnover rate of calcium</measure>
    <time_frame>24 hours</time_frame>
    <description>Elucidating whether the turnover rate of calcium in the total study population assessed by the existing compartment model correlates with markers of bone formation and bone resorption (P1NP x CTX).&#xD;
The level of significance will be adjusted for multiple testing.</description>
  </secondary_outcome>
  <enrollment type="Actual">130</enrollment>
  <condition>Osteoporosis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum sample, plasma sample, urine sample, stool sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        100 postmenopausal women aged 50- 75y having a risk for osteoporosis should be enrolled in&#xD;
        the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women&#xD;
&#xD;
          -  Age 50 - 75 years&#xD;
&#xD;
          -  Fullfilling the criteria for diagnostic examination for osteoporosis incl. DXA&#xD;
             according to DVO/ZÄS list 2015&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known fracture within the last 3 months&#xD;
&#xD;
          -  DXA within the last 12 month before inclusion&#xD;
&#xD;
          -  Substitution with sex hormones&#xD;
&#xD;
          -  Substitution with non-identified calcium supplements&#xD;
&#xD;
          -  Vitamin D deficiency (post-hoc stratifying and exclusion from primary analysis,&#xD;
             respectively)&#xD;
&#xD;
          -  Hyperparathyreoidism (by history and based on calcium, phosphate and chloride in serum&#xD;
&#xD;
          -  known renal failure&#xD;
&#xD;
          -  known cancer disease&#xD;
&#xD;
          -  Current enrollement in a clinical intervention trial&#xD;
&#xD;
          -  Enrollement in a clinical intervention trial within the last 4 weeks&#xD;
&#xD;
          -  Severe cognitive or psychiatric disorder&#xD;
&#xD;
          -  Scheduled hospitalisation before the radiological examination (DXA)&#xD;
&#xD;
          -  Legal incapacity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christiane Laue, Dr. med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Center Kiel GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Center Kiel GmbH</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>February 5, 2021</last_update_submitted>
  <last_update_submitted_qc>February 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Research Center Kiel GmbH</investigator_affiliation>
    <investigator_full_name>Dr. Christiane Laue, MD</investigator_full_name>
    <investigator_title>Dr. med (medical doctor)</investigator_title>
  </responsible_party>
  <keyword>risk factors</keyword>
  <keyword>Calcium isotopes</keyword>
  <keyword>calcium turnover</keyword>
  <keyword>DXA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02967978
org study id: GEO-Osteo-2016
nct id: NCT02967978
lead sponsor: 
collaborator: 
has dmc: Yes
The study aims at investigating whether the natural calcium isotope ratio (δ44/40Ca) in urine
      and serum differs between postmenopausal women aged 50 to 75 years suffering from
      osteoporosis and a healthy control group and whether δ44/40Ca in urine and serum can be used
      for the diagnosis of osteoporosis or whether further parameters have to be included.
According to the operational definition of WHO in the year 1994 osteoporosis is present if
      bone mineral content as assessed by DXA densitometry of the lumbar spine and/or proximal
      femur (total area or femoral neck) deviates from the mean of a 20 to 29 years old women by at
      least -2.5 standard deviations (DXA T-Score ≤ -2.5). This definition of osteoporosis is only
      valid after exclusion of other disorders, which may be associated with a reduction of bone
      mineral content and exclusion of osteomalacia.

      By an individual screening 100 women will be included in the study who are characterized
      concerning existing or non-existing osteoporosis according to the guidelines of DVO 2014 and
      ISCD 2015, respectively.

      According to the EPOS study results the prevalence of osteoporosis in Germany in
      postmenopausal women aged 50 to 60 years is about 15% and at the age of more than 70 years
      about 45%. In case of risk factors, such as hip fracture of father and/or mother, smoking,
      lactose intolerance, vegan nutrition, underweight (BMI < 20), diabetes, intake of loop
      diuretics, glucocorticoids, aromatase inhibitors and proton pump inhibitors a higher
      prevalence can be assumed. Thus by electing women with at least one risk factor of
      osteoporosis a higher proportion may meet the criteria of osteoporosis.

      Since some women are expected to present with low vitamin D levels and so far are expected to
      present with osteomalacia, and since other exclusion criteria may occur, N = 100 women will
      be investigated, in order to obtain data from N = 80 women who may meet the criteria of the
      target group (about N = 40 with osteoporosis and about N = 40 without osteoporosis (normal
      control).
observational model: Cohort
time perspective: Prospective
measure: calcium isotope ratio δ44/40Ca in urine
time frame: 24 hours
description: δ44/40Ca in urine of postmenopausal women who fulfill the criteria of osteoporosis are compared with δ44/40Ca in urine of those who do not fulfill the criteria using Mann-Whitney tests.
measure: the natural calcium isotope ratio δ44/40Ca in urine and serum (δ44/40Ca urine x serum)
time frame: 24 hours
description: Elucidating whether the natural calcium isotope ratio δ44/40Ca in urine and serum (δ44/40Caurine x serum) differ between women with and without osteoporosis. For this purpose the δ44/40Caurine x serum of women who fulfill the criteria of osteoporosis are compared with δ44/40Caurine x serum of those who do not fulfill the criteria using Mann-Whitney tests.
measure: turnover rate of calcium
time frame: 24 hours
description: Elucidating whether the turnover rate of calcium in the total study population assessed by the existing compartment model correlates with markers of bone formation and bone resorption (P1NP x CTX).
The level of significance will be adjusted for multiple testing.
serum sample, plasma sample, urine sample, stool sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christiane Laue, Dr. med
role: Principal Investigator
affiliation: Clinical Research Center Kiel GmbH
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Clinical Research Center Kiel GmbH
investigator full name: Dr. Christiane Laue, MD
investigator title: Dr. med (medical doctor)
mesh term: Osteoporosis
sharing ipd: No