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

Hyperparathyroidism, Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928408
• Other study ID #: 20070363
• Secondary ID: PRIMARA
• Status: Completed
• Start date: October 2009
• Est. completion date: February 2012

Study information

• Verified date: September 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary

Intervention

Drug:
• Cinacalcet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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. — View Citation

Outcome

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

External Links

•   AmgenTrials clinical trials website