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

Hyperparathyroidism Clinical Trial

Official title:

Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042626
• Other study ID #: NO012010
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: January 4, 2010
• Start date: July 2004
• Est. completion date: January 2005

Study information

• Verified date: January 2010
• Source: University of Eastern Piedmont
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Istituto Superiore di Sanità
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypercalcemia
• Hyperparathyroidism
• Hyperparathyroidism, Primary

Intervention

Other:
• Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

Locations

Country	Name	City	State
Italy	L. Sacco Hospital (Vialba)	Milano	MI

Sponsors (2)

Lead Sponsor	Collaborator
University of Eastern Piedmont	University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Epub 2005 Dec 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTH levels variations		2 hours	No
Primary	Ionized serum calcium variations		2 hours	No
Primary	Serum phosphate variations		2 hours	No
Primary	Serum gastrin variations		2 hours	No