HyperparathyroidismNCT01042626
Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
A study testing Oral peptones load in people with Hyperparathyroidism and Hypercalcemia, run by University of Eastern Piedmont at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperparathyroidism, Hypercalcemia
- What is being tested?
- Oral peptones load
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2004to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
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
- Being tested
- Oral peptones load
- Keywords
- Receptors, Calcium sensing, Parathyroid Hormone
- Medical subject headings
- Hyperparathyroidism, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral peptones loadOther
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Normocalcemic Hyperparathyroidism | Experimental | Not described Receives: Other: Oral peptones load |
| Hypercalcemic Hyperparathyroidism | Experimental | Not described Receives: Other: Oral peptones load |
| Healthy subjects | Active comparator | Not described Receives: Other: Oral peptones load |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTH levels variations
Measured: 2 hours
Ionized serum calcium variations
Measured: 2 hours
Serum phosphate variations
Measured: 2 hours
Serum gastrin variations
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJul 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Piedmont
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042626
- Sponsor's protocol ID
- NO012010
- Status last verified
- Jan 2010
- First submitted
- 4 Jan 2010
- Last updated
- 5 Jan 2010
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01042626
- Acronym / sponsor ID
- NO012010
- Conditions
- Hyperparathyroidism, Hypercalcemia
- Keywords
- Receptors, Calcium sensing, Parathyroid Hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Eastern PiedmontUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- Jul 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normocalcemic Hyperparathyroidism | Experimental | Other: Oral peptones load |
| Hypercalcemic Hyperparathyroidism | Experimental | Other: Oral peptones load |
| Healthy subjects | Active comparator | Other: Oral peptones load |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- normocalcemic hyperparathyroidism
- hypercalcemic hyperparathyroidism
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral peptones loadEnrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline | Other | Healthy subjects, Hypercalcemic Hyperparathyroidism, Normocalcemic Hyperparathyroidism |
Primary outcome
PTH levels variations
Time frame: 2 hours
Ionized serum calcium variations
Time frame: 2 hours
Serum phosphate variations
Time frame: 2 hours
Serum gastrin variations
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2010.
- Background: PubMed 16491288Bevilacqua 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral peptones load in people with Hyperparathyroidism and Hypercalcemia, run by University of Eastern Piedmont at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTH levels variations (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2010.