N/A N=305

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

Hyperparathyroidism, Primary

Bottom Line

View on ClinicalTrials.gov: NCT00928408 ↗

Enrolled (actual)

305

Serious AEs

0.7%

Results posted

Nov 2013

Primary outcome: Primary: Cinacalcet Dose — 43.9 mg/day

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Cinacalcet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Cinacalcet Dose	53.1	—
PRIMARY Cinacalcet Dose	53.1	—
PRIMARY Cinacalcet Dose	53.1	—
PRIMARY Cinacalcet Dose	53.1	—
PRIMARY Cinacalcet Dose	53.1	—
PRIMARY Cinacalcet Dosing Frequency	168; 118; 10; 3; 4	—
PRIMARY Cinacalcet Dosing Frequency	168; 118; 10; 3; 4	—
PRIMARY Cinacalcet Dosing Frequency	168; 118; 10; 3; 4	—
PRIMARY Cinacalcet Dosing Frequency	168; 118; 10; 3; 4	—
PRIMARY Cinacalcet Dosing Frequency	168; 118; 10; 3; 4	—
PRIMARY Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation	100; 203	—
PRIMARY Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation	45; 210	—
PRIMARY Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation	51; 182	—
PRIMARY Duration of Exposure to Cinacalcet	366	—
PRIMARY Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3	101; 79	—
PRIMARY Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6	95; 57	—
PRIMARY Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12	70; 47	—
PRIMARY Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3	138; 82	—
PRIMARY Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6	134; 59	—
PRIMARY Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12	105; 43	—
PRIMARY Change From Baseline to Month 3 in Albumin-corrected Serum Calcium	-0.32	—
PRIMARY Change From Baseline to Month 6 in Albumin-corrected Serum Calcium	-0.35	—
PRIMARY Change From Baseline to Month 12 in Albumin-corrected Serum Calcium	-0.36	—
PRIMARY Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic	0.82	—
PRIMARY Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic	-1.16	—
PRIMARY Reason for Prescribing Cinacalcet	33; 33; 107; 43; 86; 1	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00928408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.