Phosphorus and Calcium DisordersNCT03603444
Reliability of Serum Calcium to Phosphorus (Ca/P) Ratio as an Accurate and Inexpensive Tool to Define Disorders of Ca-P Metabolism
An observational study of Phosphorus and Calcium Disorders, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
BACKGROUND: Primary hyperparathyroidism (PHPT) is the third most common endocrine disorder. The Ca/P ratio is an accurate tool to differentiate patients with PHPT (>3.5 if Ca and P are expressed in mg/dl) from healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Phosphorus and Calcium Disorders
- How many people
- 606 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2011to 1 Jan 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
- 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 hypophosphoremia) and controls.
Who may be able to join
- patients with diagnosis of primary hyperparathyroidism
- HIV-infected patients with reduced phosphorus but normal calcium
- 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
Official title: Serum Calcium to Phosphorus (Ca/P) Ratio to Define Disorders of Ca-P Metabolism
BACKGROUND: Primary hyperparathyroidism (PHPT) is the third most common endocrine disorder. The Ca/P ratio is an accurate tool to differentiate patients with PHPT (>3.5 if Ca and P are expressed in mg/dl) from healthy subjects. The reliability of this index is based on the fact that serum Ca and P are inversely related together. However, other disorders of the Ca-P metabolism, such as hypophosphoremia (HypoP) not related to PHPT, might also impair the Ca/P ratio.
OBJECTIVE: To validate the accuracy of Ca/P ratio in the diagnosis of Ca-P metabolism disorders, including also patients with documented HypoP not related to PHPT.
Read more
METHODS: A single-center, retrospective, case-control study will be carried out.
Biochemical measurements will include parathormone (PTH), vitamin D, serum Ca and P, serum albumin and creatinine.
- Conditions
- Phosphorus and Calcium Disorders
- Being tested
- No intervention are provided
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 |
|---|---|---|
| First study group: patients with PHPT | 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.
Exclusion criteria for both cases and controls will be: 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. Receives: Other: No intervention are provided | |
| Second study group: patients with HypoP | Subjects with reduced serum P, but normal serum Ca, will be enrolled among HIV-infected patients on HAART treatment from the Modena cohort.
Exclusion criteria for both cases and controls will be: 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. 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 calcium-phosphorus metabolism state with normal results.
Exclusion criteria for both cases and controls will be: 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. Receives: Other: No intervention are 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 posted27 Jul 2018
- Study start1 Jan 2011
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 606 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
- NCT03603444
- Sponsor's protocol ID
- 0032443/15
- Status last verified
- Jul 2018
- First submitted
- 10 Jul 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Calcium to Phosphorus (Ca/P) Ratio to Define Disorders of Ca-P Metabolism
- ClinicalTrials.gov ID
- NCT03603444
- Acronym / sponsor ID
- 0032443/15
- Conditions
- Phosphorus and Calcium Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 27 Jul 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.
BACKGROUND: Primary hyperparathyroidism (PHPT) is the third most common endocrine disorder. The Ca/P ratio is an accurate tool to differentiate patients with PHPT (>3.5 if Ca and P are expressed in mg/dl) from healthy subjects. The reliability of this index is based on the fact that serum Ca and P are inversely related together. However, other disorders of the Ca-P metabolism, such as hypophosphoremia (HypoP) not related to PHPT, might also impair the Ca/P ratio.
OBJECTIVE: To validate the accuracy of Ca/P ratio in the diagnosis of Ca-P metabolism disorders, including also patients with documented HypoP not related to PHPT.
METHODS: A single-center, retrospective, case-control study will be carried out.
Biochemical measurements will include parathormone (PTH), vitamin D, serum Ca and P, serum albumin and creatinine.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First study group: patients with PHPT | – | 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. Exclusion criteria for both cases and controls will be: 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. |
| Second study group: patients with HypoP | – | Other: No intervention are providedSubjects with reduced serum P, but normal serum Ca, will be enrolled among HIV-infected patients on HAART treatment from the Modena cohort. Exclusion criteria for both cases and controls will be: 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. |
| Control group | – | Other: No intervention are providedPatients that underwent biochemical examination by primary care physician or by endocrinologist in order to assess their calcium-phosphorus metabolism state with normal results. Exclusion criteria for both cases and controls will be: 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- 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 hypophosphoremia) and controls.
Key inclusion criteria (3 listed)
- patients with diagnosis of primary hyperparathyroidism
- HIV-infected patients with reduced phosphorus but normal calcium
- 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 are provided | Other | Control group, First study group: patients with PHPT, Second study group: patients with HypoP |
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 27 Jul 2018.
- 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, 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 27 Jul 2018. 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?
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 27 Jul 2018.