Evaluation of a Cincalcet Suppression Test

University Hospital, Rouen

Status and phase: Completed; Phase 4

Conditions: Parathyroid Hormone Suppression Test With Cinacalcet

Treatments: Drug: cinacalcet dose 1; Drug: cinacalcet dose 2; Drug: cinacalcet

Study type: Interventional

Funder types: Other

Identifiers

NCT01103206

2009/172/HP

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Control group

Experimental group

Description:

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.

Treatment:

Drug: cinacalcet

Primary hyperparathyroidism dose I

Experimental group

Description:

Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism.

Treatment:

Drug: cinacalcet dose 1

Primary hyperparathyroidism dose II

Experimental group

Description:

Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).

Treatment:

Drug: cinacalcet dose 2