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

Completed

• Conditions: Hyperparathyroidism
• Interventions: Other: No intervention are provided

• Registration Number: NCT03027349
• Lead Sponsor: Azienda USL Modena

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	No intervention are provided	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.
Study group	No intervention are provided	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.

Primary Outcome Measures

Name	Time	Method
Calcium	Enrollment time	Assay performed at the moment of diagnosis

Secondary Outcome Measures

Name	Time	Method
Creatinine	Enrollment time	Assay performed at the moment of diagnosis
Albumine	Enrollment time	Assay performed at the moment of diagnosis
Parathormone	Enrollment time	Assay performed at the moment of diagnosis
Phosphorus	Enrollment time	Assay performed at the moment of diagnosis
Vitamin D	Enrollment time	Assay performed at the moment of diagnosis

Trial Locations

Locations (1)

Azienda USL of Modena; 🇮🇹 Modena, Italy