Evaluation of a Cincalcet Suppression Test

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Parathyroid Hormone Suppression Test With Cinacalcet

Intervention / Treatment
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* Drug: cinacalcet
* Drug: cinacalcet dose 1
* Drug: cinacalcet dose 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>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. | Drug: cinacalcet<br>* Intake of a single tablet of cinacalcet<br>|
| Experimental: Primary hyperparathyroidism dose I<br>Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism. | Drug: cinacalcet dose 1<br>* PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).<br>|
| Experimental: Primary hyperparathyroidism dose II<br>Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2). | Drug: cinacalcet dose 2<br>* Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Repeated PTH measurements for a period of 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Repeated plasma Parathyroid hormone levels for a period of 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parathyroid hormone, Cinacalcet, Primary hyperparathyroidism, Diagnosis