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.
Study Type
OBSERVATIONAL
Enrollment
305
Cinacalcet Dose
Cinacalcet dose at initiation of treatment
Time frame: Initiation of treatment
Cinacalcet Dose
Cinacalcet dose at Month 3
Time frame: Month 3
Cinacalcet Dose
Cinacalcet dose at Month 6
Time frame: Month 6
Cinacalcet Dose
Cinacalcet dose at Month 12
Time frame: Month 12
Cinacalcet Dose
Cinacalcet dose at end of treatment (last dose received)
Time frame: Up to Month 12
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at initiation of treatment
Time frame: Initiation of treatment
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 3
Time frame: Month 3
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 6
Time frame: Month 6
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 12
Time frame: Month 12
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at end of treatment
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Time frame: Up to Month 12
Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation
Time frame: Initiation to Month 3
Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation
Time frame: >3 to 6 months after initiation
Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation
Time frame: >6 months after initiation
Duration of Exposure to Cinacalcet
Time from first dose to last non-zero dose on study
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 12
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3
Time frame: Month 3
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6
Time frame: Month 6
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12
Time frame: Month 12
Change From Baseline to Month 3 in Albumin-corrected Serum Calcium
Time frame: Baseline to Month 3
Change From Baseline to Month 6 in Albumin-corrected Serum Calcium
Time frame: Baseline to Month 6
Change From Baseline to Month 12 in Albumin-corrected Serum Calcium
Time frame: 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
Time frame: 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
Time frame: Baseline to Month 12
Reason for Prescribing Cinacalcet
Time frame: Initiation