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

Sponsor

Azienda USL Modena (Other)

Overall Status

Completed

CT.gov ID

NCT03027349

Collaborator

(none)

180

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism	Other: No intervention are provided

Study Design

Study Type:

Observational

Actual Enrollment :

180 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Calcium [Enrollment time]
Assay performed at the moment of diagnosis

Secondary Outcome Measures

Phosphorus [Enrollment time]
Assay performed at the moment of diagnosis
Parathormone [Enrollment time]
Assay performed at the moment of diagnosis
Creatinine [Enrollment time]
Assay performed at the moment of diagnosis
Albumine [Enrollment time]
Assay performed at the moment of diagnosis
Vitamin D [Enrollment time]
Assay performed at the moment of diagnosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda USL of Modena	Modena		Italy	41126

Sponsors and Collaborators

Azienda USL Modena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manuela Simoni, Director, Azienda USL Modena

ClinicalTrials.gov Identifier:

NCT03027349

Other Study ID Numbers:

Primary hyperparathyroidism

First Posted:

Jan 23, 2017

Last Update Posted:

Feb 15, 2017

Last Verified:

Feb 1, 2017

Additional relevant MeSH terms:

Hyperparathyroidism

Study Results

No Results Posted as of Feb 15, 2017