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.

Study Overview

• Status: Completed
• Conditions: Hyperparathyroidism, Primary
• Intervention / Treatment: Drug: Cinacalcet

• Study Type: Observational
• Enrollment (Actual): 305

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with primary HPT receiving cinacalcet in clinical practice

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cinacalcet	Drug: Cinacalcet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Calcium-Regulating Hormones and Agents; Calcimimetic Agents; Cinacalcet
• Other Study ID Numbers: 20070363; PRIMARA