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Evaluation of a Cincalcet Suppression Test

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University Hospital, Rouen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01103206
First received: April 12, 2010
Last updated: July 26, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Parathyroid Hormone Suppression Test With Cinacalcet
 Drug: cinacalcet
Drug: cinacalcet dose 1
Drug: cinacalcet dose 2
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:

MedlinePlus related topics: Calcium
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Parathyroid hormone suppression test with cainacalcet [ Time Frame: Repeated PTH measurements for a period of 12 hours ] [ Designated as safety issue: No ]
    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:
  • Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism [ Time Frame: Repeated plasma Parathyroid hormone levels for a period of 12 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: April 2010
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: cinacalcet
Intake of a single tablet of cinacalcet
Experimental: Primary hyperparathyroidism dose I
Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism.
 Drug: cinacalcet dose 1
PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).
Experimental: Primary hyperparathyroidism dose II
Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
 Drug: cinacalcet dose 2
Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103206

Contacts
Contact: Jean Marc J Kuhn, MD 33 232 88 90 82 ext 69082 jean-marc.kuhn@chu-rouen.fr
Contact: Anne F Cailleux, MD 33 232 88 88 39 ext 68839 anne.cailleux@chu-rouen.fr

Locations
France
University hospital Recruiting
Rouen, Haute Normandie, France, 76031
Contact: Jean marc J Kuhn, MD     33 232 88 90 82 ext 69082     jean-marc.kuhn@chu-rouen.fr    
Contact: Anne F Cailleux, MD     33 232 88 88 39 ext 68839     anne.cailleux@chu-rouen.fr    
Sub-Investigator: Michel Godin, MD            
Sub-Investigator: Hervé Lefebvre, MD            
Sponsors and Collaborators
University Hospital, Rouen
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Jean Marc J Kuhn, MD University Hospital of Rouen, France:
Principal Investigator: Anne F Cailleux, MD University Hospital of Rouen, France:
  More Information

No publications provided

Responsible Party: Professor Jean Marc KUHN, University Hospital of Rouen
ClinicalTrials.gov Identifier: NCT01103206     History of Changes
Other Study ID Numbers: 2009/172/HP
Study First Received: April 12, 2010
Last Updated: July 26, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Parathyroid hormone
Cinacalcet
Primary hyperparathyroidism
Diagnosis

Additional relevant MeSH terms:
Vision, Low
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Eye Diseases
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013