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

Not Applicable

Completed

• Conditions: Hyperparathyroidism; Hypercalcemia
• Interventions: Other: Oral peptones load

• Registration Number: NCT01042626
• Lead Sponsor: University of Eastern Piedmont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Status Verified: 2010-01
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Last Update Submitted: 2010-01-04
• Study First Posted: 2010-01-05
• Last Update Posted: 2010-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normocalcemic Hyperparathyroidism	Oral peptones load	-
Hypercalcemic Hyperparathyroidism	Oral peptones load	-
Healthy subjects	Oral peptones load	-

Primary Outcome Measures

Name	Time	Method
PTH levels variations	2 hours
Ionized serum calcium variations	2 hours
Serum phosphate variations	2 hours
Serum gastrin variations	2 hours

Trial Locations

Locations (1)

L. Sacco Hospital (Vialba); 🇮🇹 Milano, MI, Italy