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

NCT ID: NCT01042626

Last Updated: 2010-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-01-31

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.

Conditions

Hyperparathyroidism; Hypercalcemia

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Normocalcemic Hyperparathyroidism

Group Type: EXPERIMENTAL

Oral peptones load

Intervention Type: OTHER

Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

Hypercalcemic Hyperparathyroidism

Group Type: EXPERIMENTAL

Oral peptones load

Intervention Type: OTHER

Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

Healthy subjects

Group Type: ACTIVE_COMPARATOR

Oral peptones load

Intervention Type: OTHER

Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

Interventions

Oral peptones load

Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Milan

OTHER

Sponsor Role: collaborator

University of Eastern Piedmont

OTHER

Sponsor Role: lead

Responsible Party

L. Sacco Hospital (Vialba)

Locations

L. Sacco Hospital (Vialba)

Milan, MI, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 16491288 (View on PubMed)

Other Identifiers

NO012010

Identifier Type: -

Identifier Source: org_study_id