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

Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747029
• Other study ID #: 352/17
• Status: Completed
• Start date: November 28, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2021
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1038
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hypoparathyroidism
• Metabolic Diseases
• Parathyroid Diseases
• Phosphorus and Calcium Disorders

Intervention

Other:
• No intervention is provided
No intervention is provided

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero - Universitaria di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Calcium to Phosphorus ratio	Calculated formula (serum calcium to serum phosphorus ratio)	Assessed only once at the diagnosis (from January 2005 to January 2018)
Secondary	Serum Calcium	From blood sample - Unit of measurement: mg/dl	Assessed only once at the diagnosis (from January 2005 to January 2018)
Secondary	Serum Phosphorus	From blood sample - Unit of measurement: mg/dl	Assessed only once at the diagnosis (from January 2005 to January 2018)
Secondary	Serum Parathormone	From blood sample - Unit of measurement: pg/ml	Assessed only once at the diagnosis (from January 2005 to January 2018)