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

A

Azienda Ospedaliero-Universitaria di Modena

Status

Completed

Conditions

Phosphorus and Calcium Disorders
Hyperparathyroidism
Parathyroid Diseases
Hypoparathyroidism

Treatments

Other: No intervention is provided

Study type

Observational

Funder types

Other

Identifiers

NCT03747029
352/17

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,038 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,038 participants in 3 patient groups

Patients with hyperparathyroidism
Description:
Patients aged between 18-90 years old with primary hyperparathyroidism. No intervention is provided.
Treatment:
Other: No intervention is provided
Patients with hypoparathyroidism
Description:
Patients aged between 18-90 years old with diagnosed hypoparathyroidism. No intervention is provided. .
Treatment:
Other: No intervention is provided
Control group
Description:
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.
Treatment:
Other: No intervention is provided

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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