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Trial record 18 of 22 for:    paget's disease of bone

Reliability of Serum Calcium to Phosphorus (Ca/P) Ratio as an Accurate and Inexpensive Tool to Define Disorders of Ca-P Metabolism

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ClinicalTrials.gov Identifier: NCT03603444
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena

Brief 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. 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.


Condition or disease Intervention/treatment
Phosphorus and Calcium Disorders Other: No intervention are provided

Study Type : Observational
Actual Enrollment : 606 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Serum Calcium to Phosphorus (Ca/P) Ratio to Define Disorders of Ca-P Metabolism
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Group/Cohort Intervention/treatment
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.

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.

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.

Other: No intervention are provided



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Serum Calcium [ Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018) ]
    From blood sample - Unit of measurement: mg/dl

  2. Serum Phosphorus [ Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018) ]
    From blood sample - Unit of measurement: mg/dl

  3. Serum Parathormone [ Time Frame: Assessed only once at the diagnosis (from January 2005 to January 2018) ]
    From blood sample - Unit of measurement: pg/ml



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • patients with diagnosis of primary hyperparathyroidism
  • HIV-infected patients with reduced phosphorus but normal calcium
  • subjects with normal Calcium-Phosphorus metabolism

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.

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): NCT03603444


Locations
Italy
Azienda Ospedaliero - Universitaria di Modena
Modena, Italy, 41124
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena

Responsible Party: Vincenzo Rochira, Professor, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier: NCT03603444     History of Changes
Other Study ID Numbers: 0032443/15
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Pathologic Processes
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs