PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
2 other identifiers
observational
305
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
November 14, 2013
CompletedAugust 1, 2018
September 1, 2015
2.2 years
June 25, 2009
February 5, 2013
July 4, 2018
Conditions
Outcome Measures
Primary Outcomes (26)
Cinacalcet Dose
Cinacalcet dose at initiation of treatment
Initiation of treatment
Cinacalcet Dose
Cinacalcet dose at Month 3
Month 3
Cinacalcet Dose
Cinacalcet dose at Month 6
Month 6
Cinacalcet Dose
Cinacalcet dose at Month 12
Month 12
Cinacalcet Dose
Cinacalcet dose at end of treatment (last dose received)
Up to Month 12
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at initiation of treatment
Initiation of treatment
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 3
Month 3
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 6
Month 6
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 12
Month 12
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at end of treatment
Up to Month 12
Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation
Initiation to Month 3
Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation
>3 to 6 months after initiation
Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation
>6 months after initiation
Duration of Exposure to Cinacalcet
Time from first dose to last non-zero dose on study
12 months
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3
Baseline is pre-cinacalcet.
Month 3
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6
Baseline is pre-cinacalcet.
Month 6
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12
Baseline is pre-cinacalcet.
Month 12
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3
Month 3
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6
Month 6
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12
Month 12
Change From Baseline to Month 3 in Albumin-corrected Serum Calcium
Baseline to Month 3
Change From Baseline to Month 6 in Albumin-corrected Serum Calcium
Baseline to Month 6
Change From Baseline to Month 12 in Albumin-corrected Serum Calcium
Baseline to Month 12
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic
Results only shown where \>10 patients have data
Baseline to Month 12
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic
Results only shown where \>10 patients have data
Baseline to Month 12
Reason for Prescribing Cinacalcet
Initiation
Study Arms (1)
Cinacalcet
Interventions
Eligibility Criteria
Adult patients with primary HPT receiving cinacalcet in clinical practice
You may qualify if:
- 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)
You may not qualify if:
- previous use of cinacalcet (other than within 1 month before enrolment)
- diagnosed secondary HPT
- other known aetiology of hypercalcaemia (eg, sarcoidosis, tuberculosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Langdahl BL, Ralston SH. Diagnosis and management of primary hyperparathyroidism in Europe. QJM. 2012 Jun;105(6):519-25. doi: 10.1093/qjmed/hcr225. Epub 2012 May 7.
PMID: 22566664BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 26, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
August 1, 2018
Results First Posted
November 14, 2013
Record last verified: 2015-09