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OpenTrials
Completed

NCT Number: NCT03027349

Serum Calcium to Phosphorous Ratio (Ca/P) as a Simple, Inexpensive Screening Tool in the Diagnosis of Primary Hyperparathyroidism

Background:

Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.

As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be considered a good candidate tool in the diagnosis of PHPT.

AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the diagnosis of PHPT.

Study design: Retrospective, observational, cross-sectional, case-control clinical trial will be carried out.

Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.

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Key information

Conditions

Hyperparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda USL of Modena

Modena, 41126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elevated parathormone serum levels
  • normal or elevated calcium serum levels

Exclusion criteria

  • age younger than 18 years
  • renal and liver failure and insufficiency
  • active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc)
  • any type of cancer
  • malnutrition, severe obesity (BMI > 40 kg/m2) and malabsorption
  • transplantation
  • sarcoidosis
  • endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism
  • familial hypocalciuric hypercalcemia
  • hypophosphoremia sustained by genetic causes or secondary to other causes.

Treatment and study plan

No intervention are provided

Other

Primary outcomes

  1. Calcium

    Time frame: Enrollment time

    Assay performed at the moment of diagnosis

Secondary outcomes

  1. Phosphorus

    Time frame: Enrollment time

    Assay performed at the moment of diagnosis

  2. Parathormone

    Time frame: Enrollment time

    Assay performed at the moment of diagnosis

  3. Creatinine

    Time frame: Enrollment time

    Assay performed at the moment of diagnosis

  4. Albumine

    Time frame: Enrollment time

    Assay performed at the moment of diagnosis

  5. Vitamin D

    Time frame: Enrollment time

    Assay performed at the moment of diagnosis

Sponsors and collaborators

Lead sponsor

Azienda USL Modena

Other

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2017
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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