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

NCT03027349 | Completed

• 1 other identifier: Primary hyperparathyroidism
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Calcium

  Assay performed at the moment of diagnosis

  Enrollment time

Secondary Outcomes (5)

• Phosphorus

  Enrollment time

• Parathormone

  Enrollment time

• Creatinine

  Enrollment time

• Albumine

  Enrollment time

• Vitamin D

  Enrollment time

Study Arms (2)

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

Interventions

No intervention are provided OTHER

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of primary hyperparathyroidism

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda USL Modena: lead

Study Sites (1)

Azienda USL of Modena

Modena, Modena, 41126, Italy

Location

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

IT (1)