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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Primary hyperparathyroidism dose I | Experimental | Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism. |
|
| Primary hyperparathyroidism dose II | Experimental | Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cinacalcet | Drug | Intake of a single tablet of cinacalcet |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Marc J Kuhn, MD | University Hospital of Rouen, France: | Study Director |
| Anne F Cailleux, MD | University Hospital of Rouen, France: | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Rouen | Haute Normandie | 76031 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25645432 | Result | 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. |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D004194 | Disease |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| cinacalcet dose 1 |
| Drug |
PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1). |
|
| cinacalcet dose 2 | Drug | Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2). |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |