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Evaluation of a Cincalcet Suppression Test

NCT ID: NCT01103206

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Parathyroid Hormone Suppression Test With Cinacalcet

Keywords

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Parathyroid hormone Cinacalcet Primary hyperparathyroidism Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control group

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.

Group Type EXPERIMENTAL

cinacalcet

Intervention Type DRUG

Intake of a single tablet of cinacalcet

Primary hyperparathyroidism dose I

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

Group Type EXPERIMENTAL

cinacalcet dose 1

Intervention Type DRUG

PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).

Primary hyperparathyroidism dose II

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

Group Type EXPERIMENTAL

cinacalcet dose 2

Intervention Type DRUG

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

Interventions

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cinacalcet

Intake of a single tablet of cinacalcet

Intervention Type DRUG

cinacalcet dose 1

PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).

Intervention Type DRUG

cinacalcet dose 2

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Marc J Kuhn, MD

Role: STUDY_DIRECTOR

University Hospital of Rouen, France:

Anne F Cailleux, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Rouen, France:

Locations

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University hospital

Rouen, Haute Normandie, France

Site Status

Countries

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France

Other Identifiers

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2009/172/HP

Identifier Type: -

Identifier Source: org_study_id