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Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

Primary Purpose

Hyperparathyroidism, Hypercalcemia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Oral peptones load
Sponsored by
University of Eastern Piedmont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperparathyroidism focused on measuring Receptors, Calcium sensing, Parathyroid Hormone

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. normocalcemic hyperparathyroidism

    • presence of high serum levels of intact PTH
    • serum ionized calcium levels in the high normality range

  2. hypercalcemic hyperparathyroidism

    • presence of high serum levels of intact PTH
    • high serum ionized calcium levels

Exclusion Criteria:

  1. potential causes of secondary hyperparathyroidism like renal insufficiency, liver disease, malabsorption, hypercalciuria, Paget's disease, thiazide diuretic or lithium use.
  2. bone disease of any origin

Sites / Locations

  • L. Sacco Hospital (Vialba)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Normocalcemic Hyperparathyroidism

Hypercalcemic Hyperparathyroidism

Healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

PTH levels variations
Ionized serum calcium variations
Serum phosphate variations
Serum gastrin variations

Secondary Outcome Measures

Full Information

First Posted
January 4, 2010
Last Updated
January 4, 2010
Sponsor
University of Eastern Piedmont
Collaborators
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT01042626
Brief Title
Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
Official Title
Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Eastern Piedmont
Collaborators
University of Milan

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess if subjects with hyperparathyroidism with normal serum calcium levels have different responses in the calcium regulating hormonal handling compared to a) patients with primary hyperparathyroidism and high serum calcium levels; b) healthy subjects. The differences will be evaluated with oral peptones load and subsequent blood samples collected every 15 minutes for two hours. Ionized calcium, phosphate, gastrin and PTH levels will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Hypercalcemia
Keywords
Receptors, Calcium sensing, Parathyroid Hormone

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normocalcemic Hyperparathyroidism
Arm Type
Experimental
Arm Title
Hypercalcemic Hyperparathyroidism
Arm Type
Experimental
Arm Title
Healthy subjects
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Oral peptones load
Intervention Description
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
Primary Outcome Measure Information:
Title
PTH levels variations
Time Frame
2 hours
Title
Ionized serum calcium variations
Time Frame
2 hours
Title
Serum phosphate variations
Time Frame
2 hours
Title
Serum gastrin variations
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: normocalcemic hyperparathyroidism presence of high serum levels of intact PTH serum ionized calcium levels in the high normality range hypercalcemic hyperparathyroidism presence of high serum levels of intact PTH high serum ionized calcium levels Exclusion Criteria: potential causes of secondary hyperparathyroidism like renal insufficiency, liver disease, malabsorption, hypercalciuria, Paget's disease, thiazide diuretic or lithium use. bone disease of any origin
Facility Information:
Facility Name
L. Sacco Hospital (Vialba)
City
Milano
State/Province
MI
ZIP/Postal Code
20157
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16491288
Citation
Bevilacqua M, Dominguez LJ, Righini V, Valdes V, Vago T, Leopaldi E, Baldi G, Barrella M, Barbagallo M. Dissimilar PTH, gastrin, and calcitonin responses to oral calcium and peptones in hypocalciuric hypercalcemia, primary hyperparathyroidism, and normal subjects: a useful tool for differential diagnosis. J Bone Miner Res. 2006 Mar;21(3):406-12. doi: 10.1359/JBMR.051210. Epub 2005 Dec 19.
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Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

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