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

This study has been completed.
Sponsor:
Collaborator:
University of Milan
Information provided by:
University of Eastern Piedmont
ClinicalTrials.gov Identifier:
NCT01042626
First received: January 4, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Hyperparathyroidism
Hypercalcemia
Other: Oral peptones load

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University of Eastern Piedmont:

Primary Outcome Measures:
  • PTH levels variations [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Ionized serum calcium variations [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Serum phosphate variations [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Serum gastrin variations [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normocalcemic Hyperparathyroidism Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
Experimental: Hypercalcemic Hyperparathyroidism Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
Active Comparator: Healthy subjects Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042626

Locations
Italy
L. Sacco Hospital (Vialba)
Milano, MI, Italy, 20157
Sponsors and Collaborators
University of Eastern Piedmont
University of Milan
  More Information

Publications:
Responsible Party: Maurizio Bevilacqua, L. Sacco Hospital (Vialba)
ClinicalTrials.gov Identifier: NCT01042626     History of Changes
Other Study ID Numbers: NO012010
Study First Received: January 4, 2010
Last Updated: January 4, 2010
Health Authority: Italy: Istituto Superiore di Sanità

Keywords provided by University of Eastern Piedmont:
Receptors, Calcium sensing
Parathyroid Hormone

Additional relevant MeSH terms:
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Calcium Metabolism Disorders
Endocrine System Diseases
Metabolic Diseases
Parathyroid Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on October 23, 2014