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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00928408
First received: June 25, 2009
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

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 (including Russia). 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.


Condition
Hyperparathyroidism, Primary

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Changes to cinalcet dose and frequency and duration of exposure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes to Serum Calcium Levels and other relevant laboratory parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Bone mass and remodelling through changes in bone mineral density (BMD) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Patient population receiving cinacalcet and reasons why [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The incidence of Adverse Drug Reactions [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cinacalcet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with primary HPT receiving cinacalcet in clinical practice

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928408

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00928408     History of Changes
Other Study ID Numbers: 20070363, PRIMARA
Study First Received: June 25, 2009
Last Updated: October 18, 2012
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement
Czech Republic: Statni ustav pro kontrolu leciv
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte
Greece: National Organization for Medicines
Italy: Agenzia Italiana del Farmaco
Netherlands: Medisch Centrum Rijnmond-Zuid, locatie Zuider
Slovakia: State Institiute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013