Study on the Use of Cinacalcet in Phosphocalcic Context. (CALCI-CINA)

Civil Hospices of Lyon

Status: Unknown

Conditions: Hyperparathyroidism, Secondary; Hyperparathyroidism, Primary

Treatments: Other: Serum PTH concentrations results

Study type: Observational

Funder types: Other

Identifiers

NCT04126954

2019_CALCI-CINA

Details and patient eligibility

About

Currently, the indications used for MA (Marketing Authorization) Cinacalcet in France are hyperparathyroidism (hyperPTH) in adults, whether primary (for patients in whom parathyroidectomy is theoretically indicated but in whom it is contraindicated or not is not clinically appropriate) or secondary to a chronic kidney disease, and parathyroid carcinomas.

In pediatric patients, data on its use are restricted due to its recent marketing authorization (2017) and limited to dialysis patients suffering from secondary hyperPTH.

Nevertheless, some patients with phosphocalcic pathologies without renal insufficiency must be treated off-label by cinacalcet in the presence of severe hyperPTH, without any other chronic treatment available to date.

The objective of this study is therefore to evaluate the use in France of cinacalcet in phosphocalcic pathologies without renal insufficiency, in order to obtain efficacy and safety data in order to improve our knowledge on the management of these orphan diseases.

Enrollment: 25 estimated patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with phosphocalcic pathology without end-stage renal failure
• Patients followed in one of the hospitals of the centers of reference and competence of the diseases of the metabolism of calcium and phosphate
• For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their on-opposition
• For adults: patient / legal guardian of the patient under guardianship having been informed of the study and expressing his or her non opposition

Exclusion criteria

• Patient suffering from parathyroid cancer,
• Patient suffering from primary hyperPTH in whom parathyroidectomy would theoretically be indicated but contraindicated or clinically inappropriate,
• Patient suffering from hyperPTH secondary to end-stage renal failure
• No social security support

Trial design

25 participants in 1 patient group

Cinacalcet

Description:

Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet

Treatment:

Other: Serum PTH concentrations results