NCT03747029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,038

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

November 16, 2018

Last Update Submit

February 8, 2021

Conditions

Phosphorus and Calcium DisordersParathyroid DiseasesHyperparathyroidismHypoparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Serum Calcium to Phosphorus ratio

    Calculated formula (serum calcium to serum phosphorus ratio)

    Assessed only once at the diagnosis (from January 2005 to January 2018)

Secondary Outcomes (3)

  • Serum Calcium

    Assessed only once at the diagnosis (from January 2005 to January 2018)

  • Serum Phosphorus

    Assessed only once at the diagnosis (from January 2005 to January 2018)

  • Serum Parathormone

    Assessed only once at the diagnosis (from January 2005 to January 2018)

Study Arms (3)

Patients with hyperparathyroidism

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

Other: No intervention is provided

Patients with hypoparathyroidism

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

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.

Other: No intervention is provided

Interventions

No intervention is providedOTHER

No intervention is provided

Control groupPatients with hyperparathyroidismPatients with hypoparathyroidism

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Serum Calcium to Phosphorus ratio will be compared among patients with different disorders of calcium-phosphorus metabolism (primary hyperparathyroidism and hypoparathyroidism) and controls.

You may qualify if:

  • patients with diagnosis of primary hyperparathyroidism
  • patients with diagnosis of hypoparathyroidism
  • subjects with normal Calcium-Phosphorus metabolism

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero - Universitaria di Modena

Modena, 41124, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32236819DERIVED

MeSH Terms

Conditions

Parathyroid DiseasesHyperparathyroidismHypoparathyroidism

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 20, 2018

Study Start

November 28, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)