Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
- Conditions
- HypoparathyroidismParathyroid DiseasesPhosphorus and Calcium DisordersHyperparathyroidism
- Interventions
- Other: No intervention is provided
- Registration Number
- NCT03747029
- Lead Sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Brief Summary
Primary hyperparathyroidism (PHPT) and Hypoparathyroidism (HP) are two of the most frequent disorder of Calcium-Phosphorus (Ca-P) metabolism. The Ca/P ratio is an accurate tool to differentiate patients with PHPT from healthy subjects, according to a previous single-centre study. The reliability of this index is based on the fact that serum Ca and P are inversely related together either in healthy subjects or in patients with PHPT and HP.
- Detailed Description
The aim of this study is to investigate the accuracy and diagnostic value of Ca/P ratio in the diagnosis of primary hyperparathyroidism and hypoparathyroidism. The definition of a valid cut-off of serum Ca/P ratio for patients with these disorders will be of help especially in those patients with apparently normal biochemical profile, but suggestive for primary hyperparathyroidism and hypoparathyroidism.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1038
- patients with diagnosis of primary hyperparathyroidism
- patients with diagnosis of hypoparathyroidism
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with hyperparathyroidism No intervention is provided Patients aged between 18-90 years old with primary hyperparathyroidism. No intervention is provided. Patients with hypoparathyroidism No intervention is provided Patients aged between 18-90 years old with diagnosed hypoparathyroidism. No intervention is provided. . Control group No intervention is 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. No intervention is provided.
- 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