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

Sponsor
Azienda Ospedaliero-Universitaria di Modena (Other)
Overall Status
Completed
CT.gov ID
NCT03747029
Collaborator
(none)
1,038
1
13.1
79.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention is provided

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 Design

Study Type:
Observational
Actual Enrollment :
1038 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
Actual Study Start Date :
Nov 28, 2017
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Serum Calcium [Assessed only once at the diagnosis (from January 2005 to January 2018)]

    From blood sample - Unit of measurement: mg/dl

  2. Serum Phosphorus [Assessed only once at the diagnosis (from January 2005 to January 2018)]

    From blood sample - Unit of measurement: mg/dl

  3. Serum Parathormone [Assessed only once at the diagnosis (from January 2005 to January 2018)]

    From blood sample - Unit of measurement: pg/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Ospedaliero - Universitaria di Modena Modena Italy 41124

Sponsors and Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vincenzo Rochira, Associate Professor, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier:
NCT03747029
Other Study ID Numbers:
  • 352/17
First Posted:
Nov 20, 2018
Last Update Posted:
Feb 9, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2021