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Study Complete
Sponsor ID
20070363

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

Sponsor ID
20070363
Clinicaltrials.gov ID
NCT00928408
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
cinacalcet hcl
Type
Observational
Masking
N/A
Enrollment
305
Additional Study Details

Protocol Summary

Primary Outcome Measures

Changes to cinalcet dose and frequency and duration of exposure

Timeframe: 12 months

Changes to Serum Calcium Levels and other relevant laboratory parameters

Timeframe: 12 months

Bone mass and remodelling through changes in bone mineral density (BMD)

Timeframe: 12 month

Patient population receiving cinacalcet and reasons why

Timeframe: 12 months

The incidence of Adverse Drug Reactions

Timeframe: 12 months

Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    Oct 2009 - Dec 2011
    Inclusion and Exclusion 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)