<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/NCT03027349</url>
  </required_header>
  <id_info>
    <org_study_id>Primary hyperparathyroidism</org_study_id>
    <nct_id>NCT03027349</nct_id>
  </id_info>
  <brief_title>Serum Calcium to Phosphorous Ratio (Ca/P) as a Simple, Inexpensive Screening Tool in the Diagnosis of Primary Hyperparathyroidism</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda USL Modena</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda USL Modena</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the&#xD;
      diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.&#xD;
&#xD;
      As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be&#xD;
      considered a good candidate tool in the diagnosis of PHPT.&#xD;
&#xD;
      AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the&#xD;
      diagnosis of PHPT.&#xD;
&#xD;
      Study design: Retrospective, observational, cross-sectional, case-control clinical trial will&#xD;
      be carried out.&#xD;
&#xD;
      Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Calcium</measure>
    <time_frame>Enrollment time</time_frame>
    <description>Assay performed at the moment of diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phosphorus</measure>
    <time_frame>Enrollment time</time_frame>
    <description>Assay performed at the moment of diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parathormone</measure>
    <time_frame>Enrollment time</time_frame>
    <description>Assay performed at the moment of diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>Enrollment time</time_frame>
    <description>Assay performed at the moment of diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumine</measure>
    <time_frame>Enrollment time</time_frame>
    <description>Assay performed at the moment of diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D</measure>
    <time_frame>Enrollment time</time_frame>
    <description>Assay performed at the moment of diagnosis</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">180</enrollment>
  <condition>Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Patients aged between 18-90 years old with primary hyperparathyroidism who had been diagnosed in the Unit of Endocrinology of the University of Modena and Reggio Emilia.&#xD;
The exclusion criteria will be:&#xD;
age younger than 18 years&#xD;
renal and liver failure and insufficiency&#xD;
active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc)&#xD;
any type of cancer&#xD;
malnutrition, severe obesity (BMI &gt; 40 kg/m2) and malabsorption&#xD;
transplantation&#xD;
sarcoidosis&#xD;
endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism&#xD;
familial hypocalciuric hypercalcemia&#xD;
hypophosphoremia sustained by genetic causes or secondary to other causes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Patients that underwent biochemical examination by primary care physician or by endocrinologist in order to assess their parathyroid function and calcium metabolism state with results into the normal ranges.&#xD;
The exclusion criteria will be:&#xD;
age younger than 18 years&#xD;
renal and liver failure and insufficiency&#xD;
active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc)&#xD;
any type of cancer&#xD;
malnutrition, severe obesity (BMI &gt; 40 kg/m2) and malabsorption&#xD;
transplantation&#xD;
sarcoidosis&#xD;
endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism&#xD;
familial hypocalciuric hypercalcemia&#xD;
hypophosphoremia sustained by genetic causes or secondary to other causes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention are provided</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosis of primary hyperparathyroidism&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elevated parathormone serum levels&#xD;
&#xD;
          -  normal or elevated calcium serum levels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age younger than 18 years&#xD;
&#xD;
          -  renal and liver failure and insufficiency&#xD;
&#xD;
          -  active metabolic bone disease (such as Paget's disease of the bone, osteomalacia,&#xD;
             rickets, etc)&#xD;
&#xD;
          -  any type of cancer&#xD;
&#xD;
          -  malnutrition, severe obesity (BMI &gt; 40 kg/m2) and malabsorption&#xD;
&#xD;
          -  transplantation&#xD;
&#xD;
          -  sarcoidosis&#xD;
&#xD;
          -  endocrinological disorders such as hypercortisolism, diabetes insipidus,&#xD;
             hyperthyroidism, pseudohypoparathyroidism&#xD;
&#xD;
          -  familial hypocalciuric hypercalcemia&#xD;
&#xD;
          -  hypophosphoremia sustained by genetic causes or secondary to other causes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda USL of Modena</name>
      <address>
        <city>Modena</city>
        <zip>41126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>February 14, 2017</last_update_submitted>
  <last_update_submitted_qc>February 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda USL Modena</investigator_affiliation>
    <investigator_full_name>Manuela Simoni</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperparathyroidism</mesh_term>
  </condition_browse>
  <!-- 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/NCT03027349
org study id: Primary hyperparathyroidism
nct id: NCT03027349
lead sponsor: 
has dmc: No
Background:

      Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the
      diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.

      As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be
      considered a good candidate tool in the diagnosis of PHPT.

      AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the
      diagnosis of PHPT.

      Study design: Retrospective, observational, cross-sectional, case-control clinical trial will
      be carried out.

      Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.
observational model: Case-Control
time perspective: Retrospective
measure: Calcium
time frame: Enrollment time
description: Assay performed at the moment of diagnosis
measure: Phosphorus
time frame: Enrollment time
description: Assay performed at the moment of diagnosis
measure: Parathormone
time frame: Enrollment time
description: Assay performed at the moment of diagnosis
measure: Creatinine
time frame: Enrollment time
description: Assay performed at the moment of diagnosis
measure: Albumine
time frame: Enrollment time
description: Assay performed at the moment of diagnosis
measure: Vitamin D
time frame: Enrollment time
description: Assay performed at the moment of diagnosis
arm group label: Study group
description: Patients aged between 18-90 years old with primary hyperparathyroidism who had been diagnosed in the Unit of Endocrinology of the University of Modena and Reggio Emilia.
The exclusion criteria will be:
age younger than 18 years
renal and liver failure and insufficiency
active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc)
any type of cancer
malnutrition, severe obesity (BMI > 40 kg/m2) and malabsorption
transplantation
sarcoidosis
endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism
familial hypocalciuric hypercalcemia
hypophosphoremia sustained by genetic causes or secondary to other causes.
arm group label: Control group
description: Patients that underwent biochemical examination by primary care physician or by endocrinologist in order to assess their parathyroid function and calcium metabolism state with results into the normal ranges.
The exclusion criteria will be:
age younger than 18 years
renal and liver failure and insufficiency
active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc)
any type of cancer
malnutrition, severe obesity (BMI > 40 kg/m2) and malabsorption
transplantation
sarcoidosis
endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism
familial hypocalciuric hypercalcemia
hypophosphoremia sustained by genetic causes or secondary to other causes.
intervention type: Other
intervention name: No intervention are provided
arm group label: Control group
arm group label: Study group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda USL Modena
investigator full name: Manuela Simoni
investigator title: Director
mesh term: Hyperparathyroidism