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Evaluation of a Cincalcet Suppression Test

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103206
First Posted: April 14, 2010
Last Update Posted: October 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Rouen
April 12, 2010
April 14, 2010
October 16, 2013
April 2010
February 2013   (Final data collection date for primary outcome measure)
Parathyroid hormone suppression test with cainacalcet [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01103206 on ClinicalTrials.gov Archive Site
Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Evaluation of a Cincalcet Suppression Test
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Parathyroid Hormone Suppression Test With Cinacalcet
  • Drug: cinacalcet
    Intake of a single tablet of cinacalcet
  • Drug: cinacalcet dose 1
    PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).
  • Drug: cinacalcet dose 2
    Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
  • 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.
    Intervention: Drug: cinacalcet
  • Experimental: Primary hyperparathyroidism dose I
    Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism.
    Intervention: Drug: cinacalcet dose 1
  • Experimental: Primary hyperparathyroidism dose II
    Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
    Intervention: Drug: cinacalcet dose 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
February 2013
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01103206
2009/172/HP
Yes
Not Provided
Not Provided
University Hospital, Rouen
University Hospital, Rouen
Institut National de la Santé Et de la Recherche Médicale, France
Study Director: Jean Marc J Kuhn, MD University Hospital of Rouen, France:
Principal Investigator: Anne F Cailleux, MD University Hospital of Rouen, France:
University Hospital, Rouen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP