PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice

Amgen

Status: Completed

Conditions: Hyperparathyroidism, Primary

Treatments: Drug: Cinacalcet

Study type: Observational

Funder types: Industry

Identifiers

NCT00928408

20070363

PRIMARA

Details and patient eligibility

About

This is a multicentre, descriptive observational study of adult patients with primary HPT receiving cinacalcet in clinical practice in a number of countries in Europe. Patients will be enrolled within 1 month of initiating cinacalcet treatment, and data will be collected prospectively for up to 1 year from initiation. Data will continue to be collected from patients discontinuing cinacalcet before the end of this period.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 18 years of age at the time of first administration of cinacalcet
• patients with primary HPT who have initiated cinacalcet within 1 month before enrolment in the study
• provision of informed consent (if required)

Exclusion criteria

• previous use of cinacalcet (other than within 1 month before enrolment)
• diagnosed secondary HPT
• other known aetiology of hypercalcaemia (eg, sarcoidosis, tuberculosis)

Trial design

305 participants in 1 patient group

Cinacalcet

Treatment:

Drug: Cinacalcet