Reliability of Serum Calcium to Phosphorus (Ca/P) Ratio as an Accurate and Inexpensive Tool to Define Disorders of Ca-P Metabolism

Phosphorus and Calcium Disorders Clinical Trial

Official title:

Serum Calcium to Phosphorus (Ca/P) Ratio to Define Disorders of Ca-P Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603444
• Other study ID #: 0032443/15
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: January 1, 2018

Study information

• Verified date: July 2018
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

BACKGROUND: Primary hyperparathyroidism (PHPT) is the third most common endocrine disorder. The Ca/P ratio is an accurate tool to differentiate patients with PHPT (>3.5 if Ca and P are expressed in mg/dl) from healthy subjects. The reliability of this index is based on the fact that serum Ca and P are inversely related together. However, other disorders of the Ca-P metabolism, such as hypophosphoremia (HypoP) not related to PHPT, might also impair the Ca/P ratio.

OBJECTIVE: To validate the accuracy of Ca/P ratio in the diagnosis of Ca-P metabolism disorders, including also patients with documented HypoP not related to PHPT.

METHODS: A single-center, retrospective, case-control study will be carried out.

Biochemical measurements will include parathormone (PTH), vitamin D, serum Ca and P, serum albumin and creatinine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients with diagnosis of primary hyperparathyroidism

• HIV-infected patients with reduced phosphorus but normal calcium

• subjects with normal Calcium-Phosphorus metabolism

Exclusion criteria for both cases and controls will be:

• age younger than 18 or older than 90 years

• severe renal and liver diseases (i.e. glomerular filtration rate (GFR) <30 ml/min)

• hyperparathyroidism secondary to Vitamin D deficiency

• active metabolic bone disease (e.g. Paget's disease of the bone, osteomalacia, rickets, etc)

• any type of cancer

• malnutrition

• severe obesity (BMI > 40 kg/m2)

• a history of gastrointestinal malabsorption

• sarcoidosis

• hypercortisolism

• diabetes insipidus

• hyperthyroidism

• pseudohypoparathyroidism

• familial hypocalciuric hypercalcemia (FHH)

• treatment with steroids, active forms of vitamin D (calcitriol, ergocalciferol, etc), thiazides, phosphate binders, lithium, cinacalcet, bisphosphonates, and denosumab.

Related Conditions & MeSH terms

• Disease
• Phosphorus and Calcium Disorders

Intervention

Other:
• No intervention are provided

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero - Universitaria di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Calcium to Phosphorus ratio	Calculated formula (serum calcium to serum phosphorus ratio)	Assessed only once at the diagnosis (from January 2005 to January 2018)
Secondary	Serum Calcium	From blood sample - Unit of measurement: mg/dl	Assessed only once at the diagnosis (from January 2005 to January 2018)
Secondary	Serum Phosphorus	From blood sample - Unit of measurement: mg/dl	Assessed only once at the diagnosis (from January 2005 to January 2018)
Secondary	Serum Parathormone	From blood sample - Unit of measurement: pg/ml	Assessed only once at the diagnosis (from January 2005 to January 2018)