Primary hyperparathyroidism in patients with MEN1 MedDRA version: 12.0 Level: LLT Classification code 10020707 Term: Hyperparathyroidism primary
Conditions
Interventions
Trade Name: MIMPARA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cinacalcet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both genders and age >18 years 2. Serum levels of PTH and calcium above the upper limit of the range of reference 3rd Normal blood count and normal liver function (ALT, AST and alkaline phosphatase in normal range and total bilirubin 50 ml/min) 4. Performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy (assessed by specific test) and lactation. The state of pregnancy during treatment involves the suspension of therapy and exit of patients from the study. 2. Creatinine clearance 8% or <5%) 7. Any serious disease with concomitant risk of life, in particular cardiovascular diseases such as heart disease of any type, uncontrolled hypertension, inastable angina and severe coronary disease 8. Patients included in a clinical treatment protocols in the last 6 months 9. Known hypersensitivity to cinacalcet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the activities of Cinacalcet- HCl administered to patients with MEN1-associated primary hyperparathyroidism (plasma PTH> 7.6 pmol / ml or 70 pg / ml and total serum calcium> 10.3 mg / dl or 2.57 mmol / l) at doses of 30 mg 1-2 times / day (starting with 30 mg per day, increasing the dose to 30 mg 2 times day, up to a maximum of 40-50 mg 2 times per day, if at the next inspection calcemia was still greater than 10.3 mg / dl or 2.57 mmol / l), considering: a) reduction or normalization of the levels of PTH and calcium; b) reducing or maintaining the size of parathyroid tissue affected;Secondary Objective: a) to evaluate changes with respect to the baseline visit of the bone turnover markers, both serum and urine levels and bone mass (expressed as Z-score); b)to assess the changes of other hormones related to MEN1 syndrome; c) to assess the safety and tolerance of the drug;Primary end point(s): Currently, there is no drug prevention or cure of the MEN1-associated primary hyperparathyroidism and the study preposes to assess whether cinacalcet can be considered as an alternative treatment for patients MEN1. | — |
Countries
Italy
Outcome results
None listed