Phosphorus and Calcium DisordersNCT03747029
Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
An observational study of Phosphorus and Calcium Disorders and Parathyroid Diseases, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Phosphorus and Calcium Disorders, Parathyroid Diseases, Hyperparathyroidism
- How many people
- 1,038 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- patients with diagnosis of primary hyperparathyroidism
- patients with diagnosis of hypoparathyroidism
- subjects with normal Calcium-Phosphorus metabolism
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Phosphorus and Calcium Disorders, Parathyroid Diseases, Hyperparathyroidism, Hypoparathyroidism
- Being tested
- No intervention is provided
- Medical subject headings
- Parathyroid Diseases, Hyperparathyroidism, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is providedOther
No intervention is provided
| Study group | Role | What they receive |
|---|---|---|
| Patients with hyperparathyroidism | Patients aged between 18-90 years old with primary hyperparathyroidism. No intervention is provided. Receives: Other: No intervention is provided | |
| Patients with hypoparathyroidism | Patients aged between 18-90 years old with diagnosed hypoparathyroidism. No intervention is provided.
. Receives: 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. Receives: Other: No intervention is provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Calcium to Phosphorus ratio
Calculated formula (serum calcium to serum phosphorus ratio)
Measured: Assessed only once at the diagnosis (from January 2005 to January 2018)
Secondary outcomes (3)
Serum Calcium
From blood sample - Unit of measurement: mg/dl
Measured: Assessed only once at the diagnosis (from January 2005 to January 2018)
Serum Phosphorus
From blood sample - Unit of measurement: mg/dl
Measured: Assessed only once at the diagnosis (from January 2005 to January 2018)
Serum Parathormone
From blood sample - Unit of measurement: pg/ml
Measured: Assessed only once at the diagnosis (from January 2005 to January 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start28 Nov 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phosphorus and Calcium DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747029
- Sponsor's protocol ID
- 352/17
- Status last verified
- Feb 2021
- First submitted
- 16 Nov 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32236819
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
- ClinicalTrials.gov ID
- NCT03747029
- Acronym / sponsor ID
- 352/17
- Conditions
- Phosphorus and Calcium Disorders, Parathyroid Diseases, Hyperparathyroidism, Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with hyperparathyroidism | – | Other: No intervention is providedPatients aged between 18-90 years old with primary hyperparathyroidism. No intervention is provided. |
| Patients with hypoparathyroidism | – | Other: No intervention is providedPatients aged between 18-90 years old with diagnosed hypoparathyroidism. No intervention is provided. . |
| Control group | – | Other: No intervention is providedPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients with diagnosis of primary hyperparathyroidism
- patients with diagnosis of hypoparathyroidism
- subjects with normal Calcium-Phosphorus metabolism
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is providedNo intervention is provided | Other | Control group, Patients with hyperparathyroidism, Patients with hypoparathyroidism |
Primary outcome
Serum Calcium to Phosphorus ratio
Time frame: Assessed only once at the diagnosis (from January 2005 to January 2018)
Calculated formula (serum calcium to serum phosphorus ratio)
3 secondary outcomes
Serum Calcium
Time frame: Assessed only once at the diagnosis (from January 2005 to January 2018)
Serum Phosphorus
Time frame: Assessed only once at the diagnosis (from January 2005 to January 2018)
Serum Parathormone
Time frame: Assessed only once at the diagnosis (from January 2005 to January 2018)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 32236819Madeo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phosphorus and Calcium Disorders and Parathyroid Diseases, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Calcium to Phosphorus ratio (time frame: Assessed only once at the diagnosis (from January 2005 to January 2018)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.