Reliability of Serum Calcium to Phosphorus (Ca/P) Ratio as an Accurate and Inexpensive Tool to Define Disorders of Ca-P Metabolism
Completed
- Conditions
- Phosphorus and Calcium Disorders
- Interventions
- Other: No intervention are provided
- Registration Number
- NCT03603444
- Lead Sponsor
- Azienda Ospedaliero-Universitaria di Modena
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 606
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description First study group: patients with PHPT No intervention are provided 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. Control group No intervention are provided 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. Second study group: patients with HypoP No intervention are provided 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.
- Primary Outcome Measures
Name Time Method Serum Calcium to Phosphorus ratio Assessed only once at the diagnosis (from January 2005 to January 2018) Calculated formula (serum calcium to serum phosphorus ratio)
- Secondary Outcome Measures
Name Time Method Serum Calcium Assessed only once at the diagnosis (from January 2005 to January 2018) From blood sample - Unit of measurement: mg/dl
Serum Phosphorus Assessed only once at the diagnosis (from January 2005 to January 2018) From blood sample - Unit of measurement: mg/dl
Serum Parathormone Assessed only once at the diagnosis (from January 2005 to January 2018) From blood sample - Unit of measurement: pg/ml
Trial Locations
- Locations (1)
Azienda Ospedaliero - Universitaria di Modena
🇮🇹Modena, Italy