Serum Calcium to Phosphorous Ratio (Ca/P) as a Simple, Inexpensive Screening Tool in the Diagnosis of Primary Hyperparathyroidism

Background:

Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.

As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be considered a good candidate tool in the diagnosis of PHPT.

AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the diagnosis of PHPT.

Study design: Retrospective, observational, cross-sectional, case-control clinical trial will be carried out.

Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.

Study Overview

• Status: Completed
• Conditions: Hyperparathyroidism
• Intervention / Treatment: Other: No intervention are provided

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41126
    • Azienda USL of Modena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of primary hyperparathyroidism

Description

Inclusion Criteria:

• elevated parathormone serum levels
• normal or elevated calcium serum levels

Exclusion Criteria:

• age younger than 18 years
• renal and liver failure and insufficiency
• active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc)
• any type of cancer
• malnutrition, severe obesity (BMI > 40 kg/m2) and malabsorption
• transplantation
• sarcoidosis
• endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism
• familial hypocalciuric hypercalcemia
• hypophosphoremia sustained by genetic causes or secondary to other causes.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients aged between 18-90 years old with primary hyperparathyroidism who had been diagnosed in the Unit of Endocrinology of the University of Modena and Reggio Emilia. The exclusion criteria will be: age younger than 18 years; renal and liver failure and insufficiency; active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc); any type of cancer; malnutrition, severe obesity (BMI > 40 kg/m2) and malabsorption; transplantation; sarcoidosis; endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism; familial hypocalciuric hypercalcemia; hypophosphoremia sustained by genetic causes or secondary to other causes.	Other: No intervention are provided
Control group; Patients that underwent biochemical examination by primary care physician or by endocrinologist in order to assess their parathyroid function and calcium metabolism state with results into the normal ranges. The exclusion criteria will be: age younger than 18 years; renal and liver failure and insufficiency; active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc); any type of cancer; malnutrition, severe obesity (BMI > 40 kg/m2) and malabsorption; transplantation; sarcoidosis; endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism; familial hypocalciuric hypercalcemia; hypophosphoremia sustained by genetic causes or secondary to other causes.	Other: No intervention are provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcium	Assay performed at the moment of diagnosis	Enrollment time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phosphorus	Assay performed at the moment of diagnosis	Enrollment time
Parathormone	Assay performed at the moment of diagnosis	Enrollment time
Creatinine	Assay performed at the moment of diagnosis	Enrollment time
Albumine	Assay performed at the moment of diagnosis	Enrollment time
Vitamin D	Assay performed at the moment of diagnosis	Enrollment time

Collaborators and Investigators

• Sponsor: Azienda USL Modena

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism
• Other Study ID Numbers: Primary hyperparathyroidism