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
- 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 ]
Original Primary Outcome:
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