Primary hyperparathyroidism in patients affected with multiple endocrine neoplasia syndrome type 1 (MEN1) MedDRA version: 9.1 Level: LLT Classification code 10027180
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Cinacalcet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of
Sponsors
OSPEDALE MAGGIORE DI MILANO (IRCCS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age > 18 years ? Total serum calcium > 10.4 mg/dl and 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
Exclusion criteria
Exclusion criteria: ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed