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

Hyperparathyroidism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027349
• Other study ID #: Primary hyperparathyroidism
• Status: Completed
• Phase: N/A
• First received: January 18, 2017
• Last updated: February 14, 2017
• Start date: January 2011
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Azienda USL Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism

Intervention

Other:
• No intervention are provided

Locations

Country	Name	City	State
Italy	Azienda USL of Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium	Assay performed at the moment of diagnosis	Enrollment time
Secondary	Phosphorus	Assay performed at the moment of diagnosis	Enrollment time
Secondary	Parathormone	Assay performed at the moment of diagnosis	Enrollment time
Secondary	Creatinine	Assay performed at the moment of diagnosis	Enrollment time
Secondary	Albumine	Assay performed at the moment of diagnosis	Enrollment time
Secondary	Vitamin D	Assay performed at the moment of diagnosis	Enrollment time