MEN-1 Primary Hyperparathyroidism Primair Hyperparathyreoidie Cinacalcet CaSR
Conditions
Interventions
Treatment with Cinacalcet (Primpara ®). Patients will be treated with cinacalcet for 1 year at a starting dose of 30 mg once daily and a maximum dose of 30 mg twice daily.
Sponsors
Leiden University Medical Center
Dutch MEN-1 Study Group
Eligibility
Inclusion criteria
Inclusion criteria: A diagnosis of primary hyperparathyroidism due to a genetically confirmed germline mutation in the MEN-1 gene.
Exclusion criteria
Exclusion criteria: 1. Sporadic primary hyperparathyroidism; 2. Autonomous hyperparathyroidism due to chronic renal failure or vitamin D deficiency; 3. Absence of genetic confirmation of a mutation in the MEN-1 gene; 4. Contraindications for MRI scanning, such as metallic fragments, pacemakers and defibrillators, nerve stimulators, intracranial clips, cochlear implants. ferromagnetic implants or claustrophobia; 5. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of cinacalcet on clinical and biochemical parameters, including bone turnover markers. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect of cinacalcet on bone mineral density, nephrocalcinosis and nephrolithiasis; 2. Effect of cinacalcet on the development and/or growth of pituitary adenomas, insulinomas, gastrinomas and/or other pancreatic tumors; 3. Is there a loss or decrease of the CaR expression in pathological specimens obtained at surgery in patients with primary hyperparathyroidism due to a MEN-I mutation? And does this influence the response to treatment with cinacalcet? | — |
Contacts
Public ContactJ.E. Witteveen
Postbus 9600
Outcome results
None listed