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

February 8, 2021 updated by: Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1038

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41124
        • Azienda Ospedaliero - Universitaria di Modena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Assessed only once at the diagnosis (from January 2005 to January 2018)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Calcium
Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018)
From blood sample - Unit of measurement: mg/dl
Assessed only once at the diagnosis (from January 2005 to January 2018)
Serum Phosphorus
Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018)
From blood sample - Unit of measurement: mg/dl
Assessed only once at the diagnosis (from January 2005 to January 2018)
Serum Parathormone
Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018)
From blood sample - Unit of measurement: pg/ml
Assessed only once at the diagnosis (from January 2005 to January 2018)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 28, 2017

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (ACTUAL)

November 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 352/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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