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Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study

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ClinicalTrials.gov Identifier: NCT03747029
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena

Study Description
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Brief Summary:
Primary hyperparathyroidism (PHPT) and Hypoparathyroidism (HP) are two of the most frequent disorder of Calcium-Phosphorus (Ca-P) metabolism. The Ca/P ratio is an accurate tool to differentiate patients with PHPT from healthy subjects, according to a previous single-centre study. The reliability of this index is based on the fact that serum Ca and P are inversely related together either in healthy subjects or in patients with PHPT and HP.

Condition or disease Intervention/treatment
Phosphorus and Calcium Disorders Parathyroid Diseases Hyperparathyroidism Hypoparathyroidism Other: No intervention is provided

Detailed Description:
The aim of this study is to investigate the accuracy and diagnostic value of Ca/P ratio in the diagnosis of primary hyperparathyroidism and hypoparathyroidism. The definition of a valid cut-off of serum Ca/P ratio for patients with these disorders will be of help especially in those patients with apparently normal biochemical profile, but suggestive for primary hyperparathyroidism and hypoparathyroidism.
Study Design
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Study Type : Observational
Actual Enrollment : 1038 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with hyperparathyroidism
Patients aged between 18-90 years old with primary hyperparathyroidism. No intervention is provided.
 Other: No intervention is provided
No intervention is provided
Patients with hypoparathyroidism

Patients aged between 18-90 years old with diagnosed hypoparathyroidism. No intervention is provided.

.

 Other: No intervention is provided
No intervention is provided
Control group

Patients that underwent biochemical examination by primary care physician or by endocrinologist in order to assess their calcium-phosphorus metabolism state with normal results.

No intervention is provided.

 Other: No intervention is provided
No intervention is provided


Outcome Measures
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Primary Outcome Measures :
  1. Serum Calcium to Phosphorus ratio [ Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018) ]
    Calculated formula (serum calcium to serum phosphorus ratio)


Secondary Outcome Measures :
  1. Serum Calcium [ Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018) ]
    From blood sample - Unit of measurement: mg/dl

  2. Serum Phosphorus [ Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018) ]
    From blood sample - Unit of measurement: mg/dl

  3. Serum Parathormone [ Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018) ]
    From blood sample - Unit of measurement: pg/ml


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Serum Calcium to Phosphorus ratio will be compared among patients with different disorders of calcium-phosphorus metabolism (primary hyperparathyroidism and hypoparathyroidism) and controls.
Criteria

Inclusion Criteria:

  • patients with diagnosis of primary hyperparathyroidism
  • patients with diagnosis of hypoparathyroidism
  • subjects with normal Calcium-Phosphorus metabolism

Exclusion Criteria for both cases and controls will be:

  • age younger than 18 or older than 90 years
  • severe renal and liver diseases (i.e. glomerular filtration rate (GFR) <30 ml/min)
  • hyperparathyroidism secondary to Vitamin D deficiency
  • active metabolic bone disease (e.g. Paget's disease of the bone, osteomalacia, rickets, etc)
  • any type of cancer
  • malnutrition
  • severe obesity (BMI > 40 kg/m2)
  • a history of gastrointestinal malabsorption
  • sarcoidosis
  • hypercortisolism
  • diabetes insipidus
  • hyperthyroidism
  • pseudohypoparathyroidism
  • familial hypocalciuric hypercalcemia (FHH)
  • treatment with steroids, active forms of vitamin D (calcitriol, ergocalciferol, etc), thiazides, phosphate binders, lithium, cinacalcet, bisphosphonates, and denosumab.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747029


Locations
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Italy
Azienda Ospedaliero - Universitaria di Modena
Modena, Italy, 41124
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vincenzo Rochira, Associate Professor, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier: NCT03747029    
Other Study ID Numbers: 352/17
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Hyperparathyroidism
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases