Clinical trial NCT00928408: PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
Official title: PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperparathyroidism, Primary
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with primary HPT receiving cinacalcet in clinical practice

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.


Eligibility 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)

Primary outcomes:
measure: Cinacalcet Dose
timeFrame: Initiation of treatment
measure: Cinacalcet Dose
timeFrame: Month 3
measure: Cinacalcet Dose
timeFrame: Month 6
measure: Cinacalcet Dose
timeFrame: Month 12
measure: Cinacalcet Dose
timeFrame: Up to Month 12
measure: Cinacalcet Dosing Frequency
timeFrame: Initiation of treatment
measure: Cinacalcet Dosing Frequency
timeFrame: Month 3
measure: Cinacalcet Dosing Frequency
timeFrame: Month 6
measure: Cinacalcet Dosing Frequency
timeFrame: Month 12
measure: Cinacalcet Dosing Frequency
timeFrame: Up to Month 12
measure: Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation
timeFrame: Initiation to Month 3
measure: Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation
timeFrame: >3 to 6 months after initiation
measure: Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation
timeFrame: >6 months after initiation
measure: Duration of Exposure to Cinacalcet
timeFrame: 12 months
measure: Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3
timeFrame: Month 3
measure: Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6
timeFrame: Month 6
measure: Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12
timeFrame: Month 12
measure: Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3
timeFrame: Month 3
measure: Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6
timeFrame: Month 6
measure: Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12
timeFrame: Month 12
measure: Change From Baseline to Month 3 in Albumin-corrected Serum Calcium
timeFrame: Baseline to Month 3
measure: Change From Baseline to Month 6 in Albumin-corrected Serum Calcium
timeFrame: Baseline to Month 6
measure: Change From Baseline to Month 12 in Albumin-corrected Serum Calcium
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic
timeFrame: Baseline to Month 12
measure: Reason for Prescribing Cinacalcet
timeFrame: Initiation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Langdahl BL, Ralston SH. Diagnosis and management of primary hyperparathyroidism in Europe. QJM. 2012 Jun;105(6):519-25. doi: 10.1093/qjmed/hcr225. Epub 2012 May 7.