Evaluation of a Cincalcet Suppression Test

NCT01103206 | Completed Phase 4 DMC

• 1 other identifier: 2009/172/HP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Parathyroid Hormone Suppression Test With Cinacalcet

Keywords

Parathyroid hormone; Cinacalcet; Primary hyperparathyroidism; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Repeated PTH measurements for a period of 12 hours

Secondary Outcomes (1)

• Parathyroid hormone suppression test with cinacalcet in primary hyperparathyroidism

  Repeated plasma Parathyroid hormone levels for a period of 12 hours

Study Arms (3)

Control group

EXPERIMENTAL

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

Primary hyperparathyroidism dose I

EXPERIMENTAL

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

Drug: cinacalcet dose 1

Primary hyperparathyroidism dose II

EXPERIMENTAL

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

Drug: cinacalcet dose 2

Interventions

cinacalcet DRUG

Intake of a single tablet of cinacalcet

Control group

cinacalcet dose 1 DRUG

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

Primary hyperparathyroidism dose I

cinacalcet dose 2 DRUG

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

Primary hyperparathyroidism dose II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

University hospital

Rouen, Haute Normandie, 76031, France

Location

Related Publications (1)

• Cailleux A, Vuillermet P, Basuyau JP, Menard JF, Lefebvre H, Kuhn JM, Prevost G. A step towards cinacalcet testing for the diagnosis of primary hyperparathyroidism: comparison with the standardized intravenous calcium loading. A pilot study. Clin Endocrinol (Oxf). 2015 May;82(5):663-9. doi: 10.1111/cen.12729. Epub 2015 Mar 5.

  PMID: 25645432 RESULT

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Disease

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jean Marc J Kuhn, MD

  University Hospital of Rouen, France:

  STUDY DIRECTOR

• Anne F Cailleux, MD

  University Hospital of Rouen, France:

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 14, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 16, 2026

Record last verified: 2013-10

Locations

FR (1)