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Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study

Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03747029
Enrollment
1038
Registered
2018-11-20
Start date
2017-11-28
Completion date
2018-12-31
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperparathyroidism, Hypoparathyroidism, Parathyroid Diseases, Phosphorus and Calcium Disorders

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.

Interventions

No intervention is provided

Sponsors

Azienda Ospedaliero-Universitaria di Modena
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Serum Calcium to Phosphorus ratioAssessed only once at the diagnosis (from January 2005 to January 2018)Calculated formula (serum calcium to serum phosphorus ratio)

Secondary

MeasureTime frameDescription
Serum CalciumAssessed only once at the diagnosis (from January 2005 to January 2018)From blood sample - Unit of measurement: mg/dl
Serum PhosphorusAssessed only once at the diagnosis (from January 2005 to January 2018)From blood sample - Unit of measurement: mg/dl
Serum ParathormoneAssessed only once at the diagnosis (from January 2005 to January 2018)From blood sample - Unit of measurement: pg/ml

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026