HyperparathyroidismNCT03027349
Serum Calcium to Phosphorous Ratio (Ca/P) as a Simple, Inexpensive Screening Tool in the Diagnosis of Primary Hyperparathyroidism
An observational study of Hyperparathyroidism, run by Azienda USL Modena at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hyperparathyroidism
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Feb 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of primary hyperparathyroidism
Who may be able to join
- elevated parathormone serum levels
- normal or elevated calcium serum levels
Who cannot join
- 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
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- sarcoidosis
- endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism
- familial hypocalciuric hypercalcemia
- hypophosphoremia sustained by genetic causes or secondary to other causes.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hyperparathyroidism
- Being tested
- No intervention are provided
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention are providedOther
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients aged between 18-90 years old with primary hyperparathyroidism who had been diagnosed in the Unit of Endocrinology of the University of Modena and Reggio Emilia.
The exclusion criteria will be:
* 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. Receives: Other: No intervention are provided | |
| Control group | Patients that underwent biochemical examination by primary care physician or by endocrinologist in order to assess their parathyroid function and calcium metabolism state with results into the normal ranges.
The exclusion criteria will be:
* 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. Receives: Other: No intervention are provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium
Assay performed at the moment of diagnosis
Measured: Enrollment time
Secondary outcomes (5)
Phosphorus
Assay performed at the moment of diagnosis
Measured: Enrollment time
Parathormone
Assay performed at the moment of diagnosis
Measured: Enrollment time
Creatinine
Assay performed at the moment of diagnosis
Measured: Enrollment time
Albumine
Assay performed at the moment of diagnosis
Measured: Enrollment time
Vitamin D
Assay performed at the moment of diagnosis
Measured: Enrollment time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Simoni, Azienda USL Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027349
- Sponsor's protocol ID
- Primary hyperparathyroidism
- Status last verified
- Feb 2017
- First submitted
- 18 Jan 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Calcium to Phosphorous Ratio (Ca/P) as a Simple, Inexpensive Screening Tool in the Diagnosis of Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03027349
- Acronym / sponsor ID
- Primary hyperparathyroidism
- Conditions
- Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Azienda USL ModenaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: No intervention are providedPatients aged between 18-90 years old with primary hyperparathyroidism who had been diagnosed in the Unit of Endocrinology of the University of Modena and Reggio Emilia. The exclusion criteria will be: * 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. |
| Control group | – | Other: No intervention are providedPatients that underwent biochemical examination by primary care physician or by endocrinologist in order to assess their parathyroid function and calcium metabolism state with results into the normal ranges. The exclusion criteria will be: * 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of primary hyperparathyroidism
Key inclusion criteria (2 listed)
- elevated parathormone serum levels
- normal or elevated calcium serum levels
Key exclusion criteria (10 listed)
- 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
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 are provided | Other | Control group, Study group |
Primary outcome
Calcium
Time frame: Enrollment time
Assay performed at the moment of diagnosis
5 secondary outcomes
Phosphorus
Time frame: Enrollment time
Parathormone
Time frame: Enrollment time
Creatinine
Time frame: Enrollment time
Albumine
Time frame: Enrollment time
Vitamin D
Time frame: Enrollment time
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 15 Feb 2017.
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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 Hyperparathyroidism, run by Azienda USL 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 2 inclusion and 10 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 15 Feb 2017. 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?
Calcium (time frame: Enrollment time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2017.