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: September 10, 2013
Last verified: September 2013
  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. 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 Intervention
Hyperparathyroidism, Primary
Drug: Cinacalcet

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:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Cinacalcet Dose [ Time Frame: Initiation of treatment ] [ Designated as safety issue: No ]
    Cinacalcet dose at initiation of treatment

  • Cinacalcet Dose [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Cinacalcet dose at Month 3

  • Cinacalcet Dose [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Cinacalcet dose at Month 6

  • Cinacalcet Dose [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Cinacalcet dose at Month 12

  • Cinacalcet Dose [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Cinacalcet dose at end of treatment (last dose received)

  • Cinacalcet Dosing Frequency [ Time Frame: Initiation of treatment ] [ Designated as safety issue: No ]
    Cinacalcet dosing frequency at initiation of treatment

  • Cinacalcet Dosing Frequency [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Cinacalcet dosing frequency at Month 3

  • Cinacalcet Dosing Frequency [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Cinacalcet dosing frequency at Month 6

  • Cinacalcet Dosing Frequency [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Cinacalcet dosing frequency at Month 12

  • Cinacalcet Dosing Frequency [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Cinacalcet dosing frequency at end of treatment

  • Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation [ Time Frame: Initiation to Month 3 ] [ Designated as safety issue: No ]
  • Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation [ Time Frame: >3 to 6 months after initiation ] [ Designated as safety issue: No ]
  • Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation [ Time Frame: >6 months after initiation ] [ Designated as safety issue: No ]
  • Duration of Exposure to Cinacalcet [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time from first dose to last non-zero dose on study

  • Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Baseline is pre-cinacalcet.

  • Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Baseline is pre-cinacalcet.

  • Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Baseline is pre-cinacalcet.

  • Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline to Month 3 in Albumin-corrected Serum Calcium [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline to Month 6 in Albumin-corrected Serum Calcium [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline to Month 12 in Albumin-corrected Serum Calcium [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    Results only shown where >10 patients have data

  • Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    Results only shown where >10 patients have data

  • Reason for Prescribing Cinacalcet [ Time Frame: Initiation ] [ 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 Assigned Interventions
Cinacalcet Drug: 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:
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
Results First Received: February 5, 2013
Last Updated: September 10, 2013
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 April 17, 2014