Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2004
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 4, 2010
CompletedFirst Posted
Study publicly available on registry
January 5, 2010
CompletedJanuary 5, 2010
January 1, 2010
6 months
January 4, 2010
January 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
PTH levels variations
2 hours
Ionized serum calcium variations
2 hours
Serum phosphate variations
2 hours
Serum gastrin variations
2 hours
Study Arms (3)
Normocalcemic Hyperparathyroidism
EXPERIMENTALHypercalcemic Hyperparathyroidism
EXPERIMENTALHealthy subjects
ACTIVE COMPARATORInterventions
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
Eligibility Criteria
You may qualify if:
- normocalcemic hyperparathyroidism
- presence of high serum levels of intact PTH
- serum ionized calcium levels in the high normality range
- hypercalcemic hyperparathyroidism
- presence of high serum levels of intact PTH
- high serum ionized calcium levels
You may not qualify if:
- potential causes of secondary hyperparathyroidism like renal insufficiency, liver disease, malabsorption, hypercalciuria, Paget's disease, thiazide diuretic or lithium use.
- bone disease of any origin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Eastern Piedmontlead
- University of Milancollaborator
Study Sites (1)
L. Sacco Hospital (Vialba)
Milan, MI, 20157, Italy
Related 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. doi: 10.1359/JBMR.051210. Epub 2005 Dec 19.
PMID: 16491288BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 4, 2010
First Posted
January 5, 2010
Study Start
July 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
January 5, 2010
Record last verified: 2010-01