Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03027349
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Manuela Simoni, Azienda USL Modena

Brief 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.

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.


Condition or disease Intervention/treatment
Hyperparathyroidism Other: No intervention are provided

Layout table for study information
Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Study Start Date : January 2011
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017


Group/Cohort Intervention/treatment
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.
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.
Other: No intervention are provided



Primary Outcome Measures :
  1. Calcium [ Time Frame: Enrollment time ]
    Assay performed at the moment of diagnosis


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of primary hyperparathyroidism
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027349


Locations
Layout table for location information
Italy
Azienda USL of Modena
Modena, Italy, 41126
Sponsors and Collaborators
Azienda USL Modena

Layout table for additonal information
Responsible Party: Manuela Simoni, Director, Azienda USL Modena
ClinicalTrials.gov Identifier: NCT03027349     History of Changes
Other Study ID Numbers: Primary hyperparathyroidism
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs