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

A

Azienda USL Modena

Status

Completed

Conditions

Hyperparathyroidism

Treatments

Other: No intervention are provided

Study type

Observational

Funder types

Other

Identifiers

NCT03027349
Primary hyperparathyroidism

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

180 participants in 2 patient groups

Study group
Description:
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.
Treatment:
Other: No intervention are provided
Control group
Description:
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.
Treatment:
Other: No intervention are provided

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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