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

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ClinicalTrials.gov Identifier: NCT00928408
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : November 14, 2013
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment
Hyperparathyroidism, Primary Drug: Cinacalcet

Study Type : Observational
Actual Enrollment : 305 participants
Time Perspective: Prospective
Official Title: PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
Study Start Date : October 2009
Primary Completion Date : December 2011
Study Completion Date : February 2012


Group/Cohort Intervention/treatment
Cinacalcet Drug: Cinacalcet



Primary Outcome Measures :
  1. Cinacalcet Dose [ Time Frame: Initiation of treatment ]
    Cinacalcet dose at initiation of treatment

  2. Cinacalcet Dose [ Time Frame: Month 3 ]
    Cinacalcet dose at Month 3

  3. Cinacalcet Dose [ Time Frame: Month 6 ]
    Cinacalcet dose at Month 6

  4. Cinacalcet Dose [ Time Frame: Month 12 ]
    Cinacalcet dose at Month 12

  5. Cinacalcet Dose [ Time Frame: Up to Month 12 ]
    Cinacalcet dose at end of treatment (last dose received)

  6. Cinacalcet Dosing Frequency [ Time Frame: Initiation of treatment ]
    Cinacalcet dosing frequency at initiation of treatment

  7. Cinacalcet Dosing Frequency [ Time Frame: Month 3 ]
    Cinacalcet dosing frequency at Month 3

  8. Cinacalcet Dosing Frequency [ Time Frame: Month 6 ]
    Cinacalcet dosing frequency at Month 6

  9. Cinacalcet Dosing Frequency [ Time Frame: Month 12 ]
    Cinacalcet dosing frequency at Month 12

  10. Cinacalcet Dosing Frequency [ Time Frame: Up to Month 12 ]
    Cinacalcet dosing frequency at end of treatment

  11. Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation [ Time Frame: Initiation to Month 3 ]
  12. Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation [ Time Frame: >3 to 6 months after initiation ]
  13. Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation [ Time Frame: >6 months after initiation ]
  14. Duration of Exposure to Cinacalcet [ Time Frame: 12 months ]
    Time from first dose to last non-zero dose on study

  15. 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 ]
    Baseline is pre-cinacalcet.

  16. 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 ]
    Baseline is pre-cinacalcet.

  17. 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 ]
    Baseline is pre-cinacalcet.

  18. Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3 [ Time Frame: Month 3 ]
  19. Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6 [ Time Frame: Month 6 ]
  20. Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12 [ Time Frame: Month 12 ]
  21. Change From Baseline to Month 3 in Albumin-corrected Serum Calcium [ Time Frame: Baseline to Month 3 ]
  22. Change From Baseline to Month 6 in Albumin-corrected Serum Calcium [ Time Frame: Baseline to Month 6 ]
  23. Change From Baseline to Month 12 in Albumin-corrected Serum Calcium [ Time Frame: Baseline to Month 12 ]
  24. 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 ]
    Results only shown where >10 patients have data

  25. 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 ]
    Results only shown where >10 patients have data

  26. Reason for Prescribing Cinacalcet [ Time Frame: Initiation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928408


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00928408     History of Changes
Other Study ID Numbers: 20070363
PRIMARA
First Posted: June 26, 2009    Key Record Dates
Results First Posted: November 14, 2013
Last Update Posted: July 25, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs