Skip to main content
OpenTrials
Completed

NCT Number: NCT03603444

Reliability of Serum Calcium to Phosphorus (Ca/P) Ratio as an Accurate and Inexpensive Tool to Define Disorders of Ca-P Metabolism

BACKGROUND: Primary hyperparathyroidism (PHPT) is the third most common endocrine disorder. The Ca/P ratio is an accurate tool to differentiate patients with PHPT (>3.5 if Ca and P are expressed in mg/dl) from healthy subjects. The reliability of this index is based on the fact that serum Ca and P are inversely related together. However, other disorders of the Ca-P metabolism, such as hypophosphoremia (HypoP) not related to PHPT, might also impair the Ca/P ratio.

OBJECTIVE: To validate the accuracy of Ca/P ratio in the diagnosis of Ca-P metabolism disorders, including also patients with documented HypoP not related to PHPT.

METHODS: A single-center, retrospective, case-control study will be carried out.

Biochemical measurements will include parathormone (PTH), vitamin D, serum Ca and P, serum albumin and creatinine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Phosphorus and Calcium Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero - Universitaria di Modena

Modena, 41124, Italy

Who can participate

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

Inclusion criteria

  • patients with diagnosis of primary hyperparathyroidism
  • HIV-infected patients with reduced phosphorus but normal calcium
  • 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 are provided

Other

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

Official study title

Serum Calcium to Phosphorus (Ca/P) Ratio to Define Disorders of Ca-P Metabolism

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2018
Registry last updated
Jul 27, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.