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Completed

NCT Number: NCT00928408

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

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.

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Key information

Conditions

Hyperparathyroidism, Primary Endocrine System Diseases Hyperparathyroidism Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cinacalcet

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 26, 2009
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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