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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01103206

Enrollment

Registered

2010-04-14

Start date

2010-04-01

Completion date

2013-02-01

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parathyroid Hormone Suppression Test With Cinacalcet

Keywords

Parathyroid hormone, Cinacalcet, Primary hyperparathyroidism, Diagnosis

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.

Interventions

DRUGcinacalcet

Intake of a single tablet of cinacalcet

DRUGcinacalcet dose 1

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

DRUGcinacalcet dose 2

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Parathyroid hormone suppression test with cainacalcet	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.

Secondary

Measure	Time frame	Description
Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism	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.

Countries

France

Contacts

STUDY_DIRECTORJean Marc J Kuhn, MD

University Hospital of Rouen, France:

PRINCIPAL_INVESTIGATORAnne F Cailleux, MD