Patients with primary hyperparathyroidism due to a germline mutation in the MEN-1 gene MedDRA version: 12.1 Level: LLT Classification code 10036693 Term: Primary hyperparathyroidism
Conditions
Interventions
Trade Name: Mimpara ®
Product Name: Mimpara
Product Code: Cinacalcet
Pharmaceutical Form: Coated tablet
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed