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

Completed

• Conditions: Hypoparathyroidism; Parathyroid Diseases; Phosphorus and Calcium Disorders; Hyperparathyroidism

• Registration Number: NCT03747029
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Modena

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.

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 Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-20
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1038

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Calcium to Phosphorus ratio	Assessed only once at the diagnosis (from January 2005 to January 2018)	Calculated formula (serum calcium to serum phosphorus ratio)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda Ospedaliero - Universitaria di Modena; 🇮🇹 Modena, Italy