Clinical trial NCT01103206: Evaluation of a Cincalcet Suppression Test
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parathyroid Hormone Suppression Test With Cinacalcet
Keywords: Parathyroid hormone
Cinacalcet
Primary hyperparathyroidism
Diagnosis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-04-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Parathyroid hormone suppression test with cainacalcet
timeFrame: Repeated PTH measurements for a period of 12 hours
Secondary outcomes:
measure: Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism
timeFrame: Repeated plasma Parathyroid hormone levels for a period of 12 hours
Other outcomes:
Locations:
city: Rouen
country: France
facility: University hospital
state: Haute Normandie
Study officials:
affiliation: University Hospital of Rouen, France:
name: Jean Marc J Kuhn, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Rouen, France:
name: Anne F Cailleux, MD
role: PRINCIPAL_INVESTIGATOR
References: