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

NCT ID: NCT03747029

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1038 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-28

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Phosphorus and Calcium Disorders Parathyroid Diseases Hyperparathyroidism Hypoparathyroidism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with hyperparathyroidism

Patients aged between 18-90 years old with primary hyperparathyroidism. No intervention is provided.

No intervention is provided

Intervention Type OTHER

No intervention is provided

Patients with hypoparathyroidism

Patients aged between 18-90 years old with diagnosed hypoparathyroidism. No intervention is provided.

.

No intervention is provided

Intervention Type OTHER

No intervention is provided

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.

No intervention is provided.

No intervention is provided

Intervention Type OTHER

No intervention is provided

Interventions

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No intervention is provided

No intervention is provided

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with diagnosis of primary hyperparathyroidism
* patients with diagnosis of hypoparathyroidism
* 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

Yes

Sponsors

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Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Rochira

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero - Universitaria di Modena

Modena, , Italy

Site Status

Countries

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Italy

References

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Madeo B, De Vincentis S, Repaci A, Altieri P, Vicennati V, Kara E, Vescini F, Amadori P, Balestrieri A, Pagotto U, Simoni M, Rochira V. The calcium-to-phosphorous (Ca/P) ratio in the diagnosis of primary hyperparathyroidism and hypoparathyroidism: a multicentric study. Endocrine. 2020 Jun;68(3):679-687. doi: 10.1007/s12020-020-02276-7. Epub 2020 Mar 31.

Reference Type DERIVED
PMID: 32236819 (View on PubMed)

Other Identifiers

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352/17

Identifier Type: -

Identifier Source: org_study_id

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