Efficacy and safety of the calcimimetic Cinacalcet in the management of patients with Primary Hyperparathyroidism due to a MEN-1 mutation - Cinacalcet in MEN-I PHPT

Conditions: Patients with primary hyperparathyroidism due to a germline mutation in the MEN-1 gene
MedDRA version: 12.1Level: LLTClassification code 10036693Term: Primary hyperparathyroidism

Registration Number: EUCTR2010-018861-53-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

A diagnosis of primary hyperparathyroidism due to a genetically confirmed germline mutation in the MEN-1 gene

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Sporadic primary hyperparathyroidism
- Autonomous hyperparathyroidism due to chronic renal failure or vitamin D deficiency
- Absence of genetic confirmation of a mutation in the MEN-1 gene
- Contraindications for MRI scanning, such as metallic fragments, pacemakers and defibrillators, nerve stimulators, intracranial clips, cochlear implants. ferromagnetic implants or claustrophobia.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy and safety of treatment with cinacalcet in patients with PHPT due a MEN-I mutation.;Secondary Objective: Determine if there is a loss or decrease of the CaR expression in pathological specimens obtained at surgery in patients with primary hyperparathyroidism due to a MEN-1 mutation.;Primary end point(s): Normalisation of serum calcium and PTH concentrations

Secondary Outcome Measures