TREATMENT OF HYPERPARATHYROIDISM IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA TYPE 1 (MEN1) WITH THE CALCIMIMETIC AGENT CINACALCET - ND
- Conditions
- Primary hyperparathyroidism in patients affected with multiple endocrine neoplasia syndrome type 1 (MEN1)MedDRA version: 9.1Level: LLTClassification code 10027180
- Registration Number
- EUCTR2008-005055-23-IT
- Lead Sponsor
- OSPEDALE MAGGIORE DI MILANO (IRCCS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
? Age > 18 years ? Total serum calcium > 10.4 mg/dl and < 13 mg/dl (at least 2 consecutive evaluations within the last 6 months) ? Ionized serum calcium > 1.32 mmol/L ? PTH > 65 pg/ml (at least 2 consecutive evaluations within the last 6 months) ? 25(OH)-vitamin D > 30 ng/ml
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) no
F.1.3.1 Number of subjects for this age range
? Pregnancy ? Chronic kidney disease ? Chronic hepatic ? Treatment with drugs metabolized by hepatic cytochrome P450 2D6 (CPY2D6), inhibitors or inducers of CYP3A4 and/or CYP1A2 ? Treatment with biphosphonates or fluoride within (60 days before baseline) ? Treatment with anti convulsive drugs or positive history of epilepsy or convulsions. ? Secondary hyperparathyroidism ? Other causes of hypercalcemia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety profile of cinacalcet, a second generation calcimimetic, in the treatment of primary hyperparathyroidism in patients with MEN 1 in whom surgery has failed or is not indicated.;Secondary Objective: To evaluate the effects of cinacalcet on renal function and complications, neuromuscular symptoms, neuropsychiatric and cognitive features, heart function, gastrointestinal symptoms and perceived quality of life.;Primary end point(s): To evaluate the efficacy and safety profile of cinacalcet, a second generation calcimimetic, in the treatment of primary HPT in patients with MEN 1 in whom surgery has failed or is not indicated, according to the NHI Consensus. The primary objective will be to assess the ability of the drug to reduce serum calcium, urinary calcium and PTH as well as to reduce/normalize bone metabolism alterations.
- Secondary Outcome Measures
Name Time Method