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Completed

NCT Number: NCT03747029

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero - Universitaria di Modena

Modena, 41124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention is provided

Other

No intervention is provided

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Modena

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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