Back to resultsEvaluation of a Cincalcet Suppression Test
Primary Purpose
Parathyroid Hormone Suppression Test With Cinacalcet
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
cinacalcet
cinacalcet dose 1
cinacalcet dose 2
Sponsored by
About this trial
This is an interventional diagnostic trial for Parathyroid Hormone Suppression Test With Cinacalcet focused on measuring Parathyroid hormone, Cinacalcet, Primary hyperparathyroidism, Diagnosis
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.
Sites / Locations
- University hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control group
Primary hyperparathyroidism dose I
Primary hyperparathyroidism dose II
Arm 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.
Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism.
Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
Outcomes
Primary Outcome Measures
Parathyroid hormone suppression test with cainacalcet
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
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.
Full Information
NCT ID
NCT01103206
First Posted
April 12, 2010
Last Updated
October 15, 2013
Sponsor
University Hospital, Rouen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01103206
Brief Title
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
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Hormone Suppression Test With Cinacalcet
Keywords
Parathyroid hormone, Cinacalcet, Primary hyperparathyroidism, Diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm 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.
Arm Title
Primary hyperparathyroidism dose I
Arm Type
Experimental
Arm Description
Parathyroid hormone suppression test using the first dose of cinacalcet in patients with primary hyperparathyroidism.
Arm Title
Primary hyperparathyroidism dose II
Arm Type
Experimental
Arm Description
Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
Intervention Type
Drug
Intervention Name(s)
cinacalcet
Intervention Description
Intake of a single tablet of cinacalcet
Intervention Type
Drug
Intervention Name(s)
cinacalcet dose 1
Intervention Description
PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).
Intervention Type
Drug
Intervention Name(s)
cinacalcet dose 2
Intervention Description
Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
Primary Outcome Measure Information:
Title
Parathyroid hormone suppression test with cainacalcet
Description
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.
Time Frame
Repeated PTH measurements for a period of 12 hours
Secondary Outcome Measure Information:
Title
Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism
Description
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.
Time Frame
Repeated plasma Parathyroid hormone levels for a period of 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Marc J Kuhn, MD
Organizational Affiliation
University Hospital of Rouen, France:
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne F Cailleux, MD
Organizational Affiliation
University Hospital of Rouen, France:
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Rouen
State/Province
Haute Normandie
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
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Evaluation of a Cincalcet Suppression Test
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