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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome:

  • Cinacalcet Dose [ Time Frame: Initiation of treatment ]
    Cinacalcet dose at initiation of treatment
  • Cinacalcet Dose [ Time Frame: Month 3 ]
    Cinacalcet dose at Month 3
  • Cinacalcet Dose [ Time Frame: Month 6 ]
    Cinacalcet dose at Month 6
  • Cinacalcet Dose [ Time Frame: Month 12 ]
    Cinacalcet dose at Month 12
  • Cinacalcet Dose [ Time Frame: Up to Month 12 ]
    Cinacalcet dose at end of treatment (last dose received)
  • Cinacalcet Dosing Frequency [ Time Frame: Initiation of treatment ]
    Cinacalcet dosing frequency at initiation of treatment
  • Cinacalcet Dosing Frequency [ Time Frame: Month 3 ]
    Cinacalcet dosing frequency at Month 3
  • Cinacalcet Dosing Frequency [ Time Frame: Month 6 ]
    Cinacalcet dosing frequency at Month 6
  • Cinacalcet Dosing Frequency [ Time Frame: Month 12 ]
    Cinacalcet dosing frequency at Month 12
  • Cinacalcet Dosing Frequency [ Time Frame: Up to Month 12 ]
    Cinacalcet dosing frequency at end of treatment

  • Original Primary Outcome:

    • Changes to cinalcet dose and frequency and duration of exposure [ Time Frame: 12 months ]
    • Changes to Serum Calcium Levels and other relevant laboratory parameters [ Time Frame: 12 months ]
    • Bone mass and remodelling through changes in bone mineral density (BMD) [ Time Frame: 12 month ]
    • Patient population receiving cinacalcet and reasons why [ Time Frame: 12 months ]
    • The incidence of Adverse Drug Reactions [ Time Frame: 12 months ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Amgen

    Dates:
    Date Received: June 25, 2009
    Date Started: October 2009
    Date Completion:
    Last Updated: July 18, 2014
    Last Verified: July 2014