Effectiviteit en veiligheid van behandeling met cinacalcet bij patiënten met primaire hyperparathyreoïdie door een MEN-I mutatie.
Recruiting
- Conditions
- MEN-1Primary HyperparathyroidismPrimair HyperparathyreoidieCinacalcetCaSR
- Registration Number
- NL-OMON23587
- Lead Sponsor
- eiden University Medical CenterDutch MEN-1 Study Group
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
A diagnosis of primary hyperparathyroidism due to a genetically confirmed germline mutation in the MEN-1 gene.
Exclusion Criteria
1. Sporadic primary hyperparathyroidism;
2. Autonomous hyperparathyroidism due to chronic renal failure or vitamin D deficiency;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effects of cinacalcet on clinical and biochemical parameters, including bone turnover markers.
- Secondary Outcome Measures
Name Time Method 1. Effect of cinacalcet on bone mineral density, nephrocalcinosis and nephrolithiasis;<br /><br>2. Effect of cinacalcet on the development and/or growth of pituitary adenomas, insulinomas, gastrinomas and/or other pancreatic tumors;<br /><br>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?