ClinicalTrials.gg
CompletedNCT01042626Updated Jan 5, 2010

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

An interventional study of Oral peptones load in Hyperparathyroidism and Hypercalcemia, sponsored by University of Eastern Piedmont. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-05.

Sponsored by University of Eastern Piedmont · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperparathyroidism
  • Hypercalcemia

Keywords

  • Receptors, Calcium sensing
  • Parathyroid Hormone
03

In context

Hyperparathyroidism

110 studies on the registry are indexed under Hyperparathyroidism; 12 are open to participants now.

This study's enrollment of 60 is above the median of 53 across 67 interventional studies indexed under Hyperparathyroidism.

Browse Hyperparathyroidism studies →

Lead sponsor

University of Eastern Piedmont is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Normocalcemic Hyperparathyroidism

    Other: Oral peptones load

  • Experimental
    Hypercalcemic Hyperparathyroidism

    Other: Oral peptones load

  • Active comparator
    Healthy subjects

    Other: Oral peptones load

Interventions

  • OtherOral peptones load

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

06

What researchers measure

Primary outcomes

  1. PTH levels variations

    Time frame: 2 hours

  2. Ionized serum calcium variations

    Time frame: 2 hours

  3. Serum phosphate variations

    Time frame: 2 hours

  4. Serum gastrin variations

    Time frame: 2 hours

07

Study locations

1 site
  • L. Sacco Hospital (Vialba)
    Milano, MI 20157, Italy
08

References and documents

Publications

  • 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. PubMed 16491288 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01042626
Lead sponsor
University of Eastern Piedmont
Collaborators
University of Milan
First posted
Jan 5, 2010
Start date
Jul 2004
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Jan 5, 2010
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion