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

NCT ID: NCT03603444

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 606 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2018-01-01

Brief 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.

Conditions

Phosphorus and Calcium Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

First study group: patients with PHPT

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.

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.

No intervention are provided

Intervention Type: OTHER

Second study group: patients with HypoP

Subjects with reduced serum P, but normal serum Ca, will be enrolled among HIV-infected patients on HAART treatment from the Modena cohort.

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.

No intervention are provided

Intervention Type: OTHER

Control group

Patients that underwent biochemical examination by primary care physician or by endocrinologist in order to assess their calcium-phosphorus metabolism state with normal results.

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.

No intervention are provided

Intervention Type: OTHER

Interventions

No intervention are provided

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role: lead

Responsible Party

Vincenzo Rochira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliero - Universitaria di Modena

Modena, , Italy

Countries

Italy

Other Identifiers

0032443/15

Identifier Type: -

Identifier Source: org_study_id