Evaluation of a Cincalcet Suppression Test
- Conditions
- Parathyroid Hormone Suppression Test With Cinacalcet
- Interventions
- Registration Number
- NCT01103206
- Lead Sponsor
- University Hospital, Rouen
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Primary hyperparathyroidism dose II cinacalcet dose 2 Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2). Control group cinacalcet 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 cinacalcet dose 1 Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism.
- Primary Outcome Measures
Name Time Method Parathyroid hormone suppression test with cainacalcet 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.
- Secondary Outcome Measures
Name Time Method Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism Repeated plasma Parathyroid hormone levels for a period of 12 hours 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.
Trial Locations
- Locations (1)
University hospital
🇫🇷Rouen, Haute Normandie, France