Parathyroid Hormone Suppression Test With CinacalcetPhase 4NCT01103206
Evaluation of a Cincalcet Suppression Test
A Phase 4 study testing cinacalcet, cinacalcet dose 1 and cinacalcet dose 2 in people with Parathyroid Hormone Suppression Test With Cinacalcet, run by University Hospital, Rouen at 1 site in France.
Trial summary
The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy adults in whom the results of the test with cinacalcet will be compared with those of the standardized PTH suppression test with… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parathyroid Hormone Suppression Test With Cinacalcet
- What is being tested?
- cinacalcet, cinacalcet dose 1 and cinacalcet dose 2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Feb 2013
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Control group: healthy adult (>18 years), having signed informed consent, taking no treatment, with effective contraception in unmenopausal women, with normal clinical examination, with normal plasma PTH, calcium, phosphorus, 25 OH vitamin D levels, with normal renal function, with normal 24 hour calciuria.
- Primary hyperparathyroidism group: adult patients (>18 years), having signed informed consent, with effective contraception in unmenopausal women, taking no treatment known to modify calcium-phosphorus status, with normal BMI, in which the diagnosis of primary hyperparathyroidism was confirmed on plasma PTH, calcium, phosphorus, 25 OH vitamin D levels, with normal renal function, with 24 hour calciuria higher than normal.
Who cannot join
- Control group: significant medical or surgical history, creatinine clearance <60 ml/min, liver insufficiency, arterial hypertension, psychiatric disorder able to modify the compliance to the study, tobacco intoxication, taking a treatment known to modify calcium-phosphorus status, severe known allergy, pregnant women, unmenopaused women without contraception.
- Primary hyperparathyroidism group:secondary hyperparathyroidism, creatinine clearance <60 ml/min, liver insufficiency, psychiatric disorder able to modify the compliance to the study, tobacco intoxication, taking a treatment known to modify calcium-phosphorus status, severe known allergy, pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Parathyroid Hormone Suppression Test With Cinacalcet. Comparison: 1- With the Results of the Intravenous Calcium Suppression Test in Healthy Controls; 2- Between Healthy Controls and Patients With Primary Hyperparathyroidism.
The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy adults in whom the results of the test with cinacalcet will be compared with those of the standardized PTH suppression test with intravenous calcium loading; 2- a group of patients with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will be compared with those obtained during the same test, in healthy controls.
- Being tested
- cinacalcet, cinacalcet dose 1, cinacalcet dose 2
- Keywords
- Parathyroid hormone, Cinacalcet, Primary hyperparathyroidism, Diagnosis
- Medical subject headings
- Hyperparathyroidism, Primary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinacalcetDrug
Intake of a single tablet of cinacalcet
cinacalcet dose 1Drug
PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).
cinacalcet dose 2Drug
Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Parathyroid hormone suppression tests using successively (each test will be separate for a two week period) an intravenous calcium loading or cinacalcet will be performed in a group of 12 healthy volunteers. Receives: Drug: cinacalcet |
| Primary hyperparathyroidism dose I | Experimental | Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism. Receives: Drug: cinacalcet dose 1 |
| Primary hyperparathyroidism dose II | Experimental | Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2). Receives: Drug: cinacalcet dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parathyroid hormone suppression test with cainacalcet
Comparison of the plasma parathyroid hormone levels measured in healthy controls during two tests: a test using a single oral dose of cinacalcet and a test using a standardized intravenous calcium loading.
Measured: Repeated PTH measurements for a period of 12 hours
Secondary outcomes (1)
Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism
Comparison of the results obtained in patients with primary hyperparathyroidism during a cinacalcet suppression test with those obtained using the same test in healthy controls.
Measured: Repeated plasma Parathyroid hormone levels for a period of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2013
- Study completionFeb 2013
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 Parathyroid Hormone Suppression Test With CinacalcetStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc J Kuhn, MD, Study director, University Hospital of Rouen, France:Anne F Cailleux, MD, Principal investigator, University Hospital of Rouen, France:
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103206
- Sponsor's protocol ID
- 2009/172/HP
- Status last verified
- Oct 2013
- First submitted
- 12 Apr 2010
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cailleux A, Vuillermet P, Basuyau JP, Menard JF, Lefebvre H, Kuhn JM, Prevost G. A step towards cinacalcet testing for the diagnosis of primary hyperparathyroidism: comparison with the standardized intravenous calcium loading. A pilot study. Clin Endocrinol (Oxf). 2015 May;82(5):663-9. doi: 10.1111/cen.12729. Epub 2015 Mar 5.
PubMed 25645432
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Parathyroid Hormone Suppression Test With Cinacalcet. Comparison: 1- With the Results of the Intravenous Calcium Suppression Test in Healthy Controls; 2- Between Healthy Controls and Patients With Primary Hyperparathyroidism.
- ClinicalTrials.gov ID
- NCT01103206
- Acronym / sponsor ID
- 2009/172/HP
- Keywords
- Parathyroid hormone, Cinacalcet, Primary hyperparathyroidism, Diagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Apr 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Apr 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 aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy adults in whom the results of the test with cinacalcet will be compared with those of the standardized PTH suppression test with intravenous calcium loading; 2- a group of patients with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will be compared with those obtained during the same test, in healthy controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: cinacalcetParathyroid hormone suppression tests using successively (each test will be separate for a two week period) an intravenous calcium loading or cinacalcet will be performed in a group of 12 healthy volunteers. |
| Primary hyperparathyroidism dose I | Experimental | Drug: cinacalcet dose 1Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism. |
| Primary hyperparathyroidism dose II | Experimental | Drug: cinacalcet dose 2Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Control group: healthy adult (>18 years), having signed informed consent, taking no treatment, with effective contraception in unmenopausal women, with normal clinical examination, with normal plasma PTH, calcium, phosphorus, 25 OH vitamin D levels, with normal renal function, with normal 24 hour calciuria.
- Primary hyperparathyroidism group: adult patients (>18 years), having signed informed consent, with effective contraception in unmenopausal women, taking no treatment known to modify calcium-phosphorus status, with normal BMI, in which the diagnosis of primary hyperparathyroidism was confirmed on plasma PTH, calcium, phosphorus, 25 OH vitamin D levels, with normal renal function, with 24 hour calciuria higher than normal.
Key exclusion criteria (2 listed)
- Control group: significant medical or surgical history, creatinine clearance <60 ml/min, liver insufficiency, arterial hypertension, psychiatric disorder able to modify the compliance to the study, tobacco intoxication, taking a treatment known to modify calcium-phosphorus status, severe known allergy, pregnant women, unmenopaused women without contraception.
- Primary hyperparathyroidism group:secondary hyperparathyroidism, creatinine clearance <60 ml/min, liver insufficiency, psychiatric disorder able to modify the compliance to the study, tobacco intoxication, taking a treatment known to modify calcium-phosphorus status, severe known allergy, pregnant women.
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 |
|---|---|---|
| cinacalcetIntake of a single tablet of cinacalcet | Drug | Control group |
| cinacalcet dose 1PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1). | Drug | Primary hyperparathyroidism dose I |
| cinacalcet dose 2Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2). | Drug | Primary hyperparathyroidism dose II |
Primary outcome
Parathyroid hormone suppression test with cainacalcet
Time frame: Repeated PTH measurements for a period of 12 hours
Comparison of the plasma parathyroid hormone levels measured in healthy controls during two tests: a test using a single oral dose of cinacalcet and a test using a standardized intravenous calcium loading.
1 secondary outcome
Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism
Time frame: Repeated plasma Parathyroid hormone levels for a period of 12 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 16 Apr 2026.
- Results publication: PubMed 25645432Cailleux A, Vuillermet P, Basuyau JP, Menard JF, Lefebvre H, Kuhn JM, Prevost G. A step towards cinacalcet testing for the diagnosis of primary hyperparathyroidism: comparison with the standardized intravenous calcium loading. A pilot study. Clin Endocrinol (Oxf). 2015 May;82(5):663-9. doi: 10.1111/cen.12729. Epub 2015 Mar 5.
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.
Jean Marc J Kuhn, MD study director
University Hospital of Rouen, France:
Anne F Cailleux, MD principal investigator
University Hospital of Rouen, France:
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cinacalcet, cinacalcet dose 1 and cinacalcet dose 2 in people with Parathyroid Hormone Suppression Test With Cinacalcet, run by University Hospital, Rouen at 1 site in France.
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 2 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 16 Apr 2026. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parathyroid hormone suppression test with cainacalcet (time frame: Repeated PTH measurements for a period of 12 hours). 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 NCT01103206, 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 16 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.