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

Completed

• Conditions: Hyperparathyroidism, Primary
• Interventions: Drug: Cinacalcet

• Registration Number: NCT00928408
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Study Start: 2009-10
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Results First Submitted: 2013-02-05
• Results First Submitted QC: 2013-09-10
• Results First Posted: 2013-11-14
• Status Verified: 2015-09
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cinacalcet	Cinacalcet	-

Primary Outcome Measures

Name	Time	Method
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
Cinacalcet Dosing Frequency	Up to Month 12	Cinacalcet dosing frequency at end of treatment
Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation	Initiation to Month 3
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
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic	Baseline to Month 12	Results only shown where \>10 patients have data
Cinacalcet Dose	Up to Month 12	Cinacalcet dose at end of treatment (last dose received)
Duration of Exposure to Cinacalcet	12 months	Time from first dose to last non-zero dose on study
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3	Month 3	Baseline is pre-cinacalcet.
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6	Month 6	Baseline is pre-cinacalcet.
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12	Month 12	Baseline is pre-cinacalcet.
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
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic	Baseline to Month 12	Results only shown where \>10 patients have data
Change From Baseline to Month 12 in Albumin-corrected Serum Calcium	Baseline to Month 12
Reason for Prescribing Cinacalcet	Initiation