Trial Outcomes & Findings for PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice (NCT NCT00928408)

NCT ID: NCT00928408

Last Updated: 2018-08-01

Results Overview

Cinacalcet dose at initiation of treatment

• Recruitment status: COMPLETED
• Target enrollment: 305 participants
• Primary outcome timeframe: Initiation of treatment
• Results posted on: 2018-08-01

Participant Flow

Participant milestones

Measure	Cinacalcet
Overall Study STARTED	305
Overall Study Full Analysis Set	303
Overall Study COMPLETED	282
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	Cinacalcet
Overall Study Other	2
Overall Study Withdrawal by Subject	4
Overall Study Death	5
Overall Study Lost to Follow-up	12

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cinacalcet n=303 Participants
Age, Continuous	67.4 Years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	241 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	104 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasion	199 Participants n=5 Participants

PRIMARY outcome

Timeframe: Initiation of treatment

Population: Full Analysis Set

Cinacalcet dose at initiation of treatment

Outcome measures

Measure	Cinacalcet n=303 Participants
Cinacalcet Dose	43.9 mg/day 95% Confidence Interval 0.9 • Interval 42.1 to 45.7

PRIMARY outcome

Timeframe: Month 3

Population: Full Analysis Set - Participants with Observed Data

Cinacalcet dose at Month 3

Outcome measures

Measure	Cinacalcet n=255 Participants
Cinacalcet Dose	48.7 mg/day 95% Confidence Interval 0.9 • Interval 44.9 to 52.5

PRIMARY outcome

Timeframe: Month 6

Population: Full Analysis Set - Participants with Observed Data

Cinacalcet dose at Month 6

Outcome measures

Measure	Cinacalcet n=233 Participants
Cinacalcet Dose	48.9 mg/day 95% Confidence Interval 0.9 • Interval 44.9 to 52.8

PRIMARY outcome

Timeframe: Month 12

Population: Full Analysis Set - Participants with Observed Data

Cinacalcet dose at Month 12

Outcome measures

Measure	Cinacalcet n=219 Participants
Cinacalcet Dose	51.3 mg/day 95% Confidence Interval 0.9 • Interval 47.0 to 55.5

PRIMARY outcome

Timeframe: Up to Month 12

Population: Full Analysis Set

Cinacalcet dose at end of treatment (last dose received)

Outcome measures

Measure	Cinacalcet n=303 Participants
Cinacalcet Dose	53.1 mg/day 95% Confidence Interval 0.9 • Interval 49.2 to 57.0

PRIMARY outcome

Timeframe: Initiation of treatment

Population: Full Analysis Set

Cinacalcet dosing frequency at initiation of treatment

Outcome measures

Measure	Cinacalcet n=303 Participants
Cinacalcet Dosing Frequency Once a day	169 Participants 0.9 • Interval 49.2 to 57.0
Cinacalcet Dosing Frequency Twice a day	134 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Full Analysis Set - Participants with Observed Data

Cinacalcet dosing frequency at Month 3

Outcome measures

Measure	Cinacalcet n=255 Participants
Cinacalcet Dosing Frequency Once a day	133 Participants 0.9 • Interval 49.2 to 57.0
Cinacalcet Dosing Frequency Twice a day	107 Participants
Cinacalcet Dosing Frequency Three times a day	4 Participants
Cinacalcet Dosing Frequency Four times a day	1 Participants
Cinacalcet Dosing Frequency Dose withheld	6 Participants
Cinacalcet Dosing Frequency Other	4 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Full Analysis Set - Participants with Observed Data

Cinacalcet dosing frequency at Month 6

Outcome measures

Measure	Cinacalcet n=233 Participants
Cinacalcet Dosing Frequency Once a day	128 Participants 0.9 • Interval 49.2 to 57.0
Cinacalcet Dosing Frequency Twice a day	94 Participants
Cinacalcet Dosing Frequency Three times a day	4 Participants
Cinacalcet Dosing Frequency Dose withheld	3 Participants
Cinacalcet Dosing Frequency Other	4 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Full Analysis Set - Participants with Observed Data

Cinacalcet dosing frequency at Month 12

Outcome measures

Measure	Cinacalcet n=219 Participants
Cinacalcet Dosing Frequency Once a day	121 Participants 0.9 • Interval 49.2 to 57.0
Cinacalcet Dosing Frequency Twice a day	88 Participants
Cinacalcet Dosing Frequency Three times a day	6 Participants
Cinacalcet Dosing Frequency Other	4 Participants

PRIMARY outcome

Timeframe: Up to Month 12

Population: Full Analysis Set

Cinacalcet dosing frequency at end of treatment

Outcome measures

Measure	Cinacalcet n=303 Participants
Cinacalcet Dosing Frequency Once a day	168 Participants 0.9 • Interval 49.2 to 57.0
Cinacalcet Dosing Frequency Twice a day	118 Participants
Cinacalcet Dosing Frequency Three times a day	10 Participants
Cinacalcet Dosing Frequency Four times a day	3 Participants
Cinacalcet Dosing Frequency Other	4 Participants

PRIMARY outcome

Timeframe: Initiation to Month 3

Population: Full Analysis Set

Outcome measures

Measure	Cinacalcet n=303 Participants
Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation Yes	100 Participants 0.9 • Interval 49.2 to 57.0
Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation No	203 Participants

PRIMARY outcome

Timeframe: >3 to 6 months after initiation

Population: Full Analysis Set - Participants with Observed Data

Outcome measures

Measure	Cinacalcet n=255 Participants
Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation Yes	45 Participants 0.9 • Interval 49.2 to 57.0
Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation No	210 Participants

PRIMARY outcome

Timeframe: >6 months after initiation

Population: Full Analysis Set - Participants with Observed Data

Outcome measures

Measure	Cinacalcet n=233 Participants
Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation Yes	51 Participants 0.9 • Interval 49.2 to 57.0
Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation No	182 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Full Analysis Set

Time from first dose to last non-zero dose on study

Outcome measures

Measure	Cinacalcet n=303 Participants
Duration of Exposure to Cinacalcet	366 Days Inter-Quartile Range 7.3 • Interval 232.0 to 366.0

PRIMARY outcome

Timeframe: Month 3

Population: Full Analysis Set - Participants with Observed Data

Baseline is pre-cinacalcet.

Outcome measures

Measure	Cinacalcet n=180 Participants
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3 Yes	101 Participants 0.9 • Interval 49.2 to 57.0
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3 No	79 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Full Analysis Set - Participants with Observed Data

Baseline is pre-cinacalcet.

Outcome measures

Measure	Cinacalcet n=152 Participants
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6 Yes	95 Participants 0.9 • Interval 49.2 to 57.0
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6 No	57 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Full Analysis Set - Participants with Observed Data

Baseline is pre-cinacalcet.

Outcome measures

Measure	Cinacalcet n=117 Participants
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12 Yes	70 Participants 0.9 • Interval 49.2 to 57.0
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12 No	47 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Full Analysis Set - Participants with Observed Data

Outcome measures

Measure	Cinacalcet n=220 Participants
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3 Yes	138 Participants 0.9 • Interval 49.2 to 57.0
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3 No	82 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Full Analysis Set - Participants with Observed Data

Outcome measures

Measure	Cinacalcet n=193 Participants
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6 Yes	134 Participants 0.9 • Interval 49.2 to 57.0
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6 No	59 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Full Analysis Set - Participants with Observed Data

Outcome measures

Measure	Cinacalcet n=148 Participants
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12 Yes	105 Participants 0.9 • Interval 49.2 to 57.0
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12 No	43 Participants

PRIMARY outcome

Timeframe: Baseline to Month 3

Population: Full Analysis Set - Participants with Observed Data

Outcome measures

Measure	Cinacalcet n=161 Participants
Change From Baseline to Month 3 in Albumin-corrected Serum Calcium	-0.32 mmol/L Standard Error 0.02

PRIMARY outcome

Timeframe: Baseline to Month 6

Population: Full Analysis Set - Participants with Observed Data

Outcome measures

Measure	Cinacalcet n=127 Participants
Change From Baseline to Month 6 in Albumin-corrected Serum Calcium	-0.35 mmol/L Standard Error 0.03

PRIMARY outcome

Timeframe: Baseline to Month 12

Population: Full Analysis Set - Participants with Observed Data

Outcome measures

Measure	Cinacalcet n=109 Participants
Change From Baseline to Month 12 in Albumin-corrected Serum Calcium	-0.36 mmol/L Standard Error 0.03

PRIMARY outcome

Timeframe: Baseline to Month 12

Population: Full Analysis Set - Participants with Observed Data

Results only shown where >10 patients have data

Outcome measures

Measure	Cinacalcet n=14 Participants
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic	0.82 Percent change Inter-Quartile Range 5.26 • Interval -1.63 to 2.91

PRIMARY outcome

Timeframe: Baseline to Month 12

Population: Full Analysis Set - Participants with Observed Data

Results only shown where >10 patients have data

Outcome measures

Measure	Cinacalcet n=19 Participants
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic	-1.16 Percent change Inter-Quartile Range 9.56 • Interval -3.89 to 2.7

PRIMARY outcome

Timeframe: Initiation

Population: Full Analysis Set

Outcome measures

Measure	Cinacalcet n=303 Participants
Reason for Prescribing Cinacalcet Surgery contraindicated	33 Participants
Reason for Prescribing Cinacalcet Failed surgery	33 Participants 0.9 • Interval 49.2 to 57.0
Reason for Prescribing Cinacalcet Surgery not considered appropriate by physician	107 Participants
Reason for Prescribing Cinacalcet Reduction of hypercalcaemia before surgery	43 Participants
Reason for Prescribing Cinacalcet Surgery declined by patient	86 Participants
Reason for Prescribing Cinacalcet Other	1 Participants

Adverse Events

Cinacalcet

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cinacalcet n=303 participants at risk
Metabolism and nutrition disorders Hypocalcaemia	0.33% 1/303 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Only adverse drug reactions to cinacalcet were collected. Analysis is based on the Full Analysis Set (all enrolled who fulfilled study inclusion/exclusion criteria).
Musculoskeletal and connective tissue disorders Muscle spasms	0.33% 1/303 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Only adverse drug reactions to cinacalcet were collected. Analysis is based on the Full Analysis Set (all enrolled who fulfilled study inclusion/exclusion criteria).
Vascular disorders Circulatory collapse	0.33% 1/303 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Only adverse drug reactions to cinacalcet were collected. Analysis is based on the Full Analysis Set (all enrolled who fulfilled study inclusion/exclusion criteria).

Other adverse events

Measure	Cinacalcet n=303 participants at risk
Gastrointestinal disorders Nausea	13.5% 41/303 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Only adverse drug reactions to cinacalcet were collected. Analysis is based on the Full Analysis Set (all enrolled who fulfilled study inclusion/exclusion criteria).

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER