Parathyroid Hormone Suppression Test With Cinacalcet Clinical Trial
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | University hospital | Rouen | Haute Normandie |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen | Institut National de la Santé Et de la Recherche Médicale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |