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

NCT ID: NCT03027349

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-02-28

Brief Summary

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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

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Conditions

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Hyperparathyroidism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No intervention are provided

Intervention Type OTHER

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.

No intervention are provided

Intervention Type OTHER

Interventions

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No intervention are provided

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL Modena

OTHER

Sponsor Role lead

Responsible Party

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Manuela Simoni

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda USL of Modena

Modena, Modena, Italy

Site Status

Countries

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Italy

Other Identifiers

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Primary hyperparathyroidism

Identifier Type: -

Identifier Source: org_study_id

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