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CompletedNCT01103206Updated Apr 16, 2026

Evaluation of a Cincalcet Suppression Test

A Phase 4 interventional study of cinacalcet and cinacalcet dose 1 in Parathyroid Hormone Suppression Test With Cinacalcet, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by University Hospital, Rouen · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parathyroid Hormone Suppression Test With Cinacalcet

Keywords

  • Parathyroid hormone
  • Cinacalcet
  • Primary hyperparathyroidism
  • Diagnosis
03

In context

Hyperparathyroidism, Primary

104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.

This study's enrollment of 36 is below the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Control group: healthy adult (>18 years), having signed , taking no treatment, with effective 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 , 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

Exclusion Criteria:

  • Control group: significant medical or surgical history, \<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 .
  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • 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

  • Experimental
    Primary hyperparathyroidism dose I

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

    Drug: cinacalcet dose 1

  • Experimental
    Primary hyperparathyroidism dose II

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

    Drug: cinacalcet dose 2

Interventions

  • 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).

06

What researchers measure

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.

    Time frame: Repeated PTH measurements for a period of 12 hours

Secondary outcomes

  1. 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.

    Time frame: Repeated plasma Parathyroid hormone levels for a period of 12 hours

07

Study locations

1 site
  • University hospital
    Rouen, Haute Normandie 76031, France
08

References and documents

Publications

  • 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. PubMed 25645432 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01103206
Responsible party
Sponsor
First posted
Apr 14, 2010
Start date
Apr 2010
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Apr 16, 2026

Study contacts

Jean Marc J Kuhn, MD
study director · University Hospital of Rouen, France:
Anne F Cailleux, MD
principal investigator · University Hospital of Rouen, France:

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cinacalcet

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