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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014