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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperparathyroidism, Primary

Intervention / Treatment
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* Drug: Cinacalcet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cinacalcet<br> | Drug: Cinacalcet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |