Hyperparathyroidism, Primary
Conditions
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.
Interventions
DRUGCinacalcet
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cinacalcet Dose | Initiation of treatment | Cinacalcet dose at initiation of treatment |
| Cinacalcet Dosing Frequency | Initiation of treatment | Cinacalcet dosing frequency at initiation of treatment |
| 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 | 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 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 | Baseline to Month 12 | Results only shown where \>10 patients have data |
| 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 |
| Reason for Prescribing Cinacalcet | Initiation | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cinacalcet | 303 |
| Total | 303 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Other | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Cinacalcet |
|---|---|
| Age, Continuous | 67.4 Years STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 104 Participants |
| Race/Ethnicity, Customized White or Caucasion | 199 Participants |
| Sex: Female, Male Female | 241 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 303 |
| serious Total, serious adverse events | 2 / 303 |
Outcome results
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.
Time frame: Month 12
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | 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 |
| Cinacalcet | 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
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.
Time frame: Month 3
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | 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 |
| Cinacalcet | 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
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.
Time frame: Month 6
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | 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 |
| Cinacalcet | 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
Change From Baseline to Month 12 in Albumin-corrected Serum Calcium
Time frame: Baseline to Month 12
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Change From Baseline to Month 12 in Albumin-corrected Serum Calcium | -0.36 mmol/L | Standard Error 0.03 |
Primary
Change From Baseline to Month 3 in Albumin-corrected Serum Calcium
Time frame: Baseline to Month 3
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Change From Baseline to Month 3 in Albumin-corrected Serum Calcium | -0.32 mmol/L | Standard Error 0.02 |
Primary
Change From Baseline to Month 6 in Albumin-corrected Serum Calcium
Time frame: Baseline to Month 6
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Change From Baseline to Month 6 in Albumin-corrected Serum Calcium | -0.35 mmol/L | Standard Error 0.03 |
Primary
Cinacalcet Dose
Cinacalcet dose at Month 3
Time frame: Month 3
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Cinacalcet Dose | 48.7 mg/day | 95% Confidence Interval 0.9 |
Primary
Cinacalcet Dose
Cinacalcet dose at end of treatment (last dose received)
Time frame: Up to Month 12
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Cinacalcet Dose | 53.1 mg/day | 95% Confidence Interval 0.9 |
Primary
Cinacalcet Dose
Cinacalcet dose at Month 12
Time frame: Month 12
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Cinacalcet Dose | 51.3 mg/day | 95% Confidence Interval 0.9 |
Primary
Cinacalcet Dose
Cinacalcet dose at initiation of treatment
Time frame: Initiation of treatment
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Cinacalcet Dose | 43.9 mg/day | 95% Confidence Interval 0.9 |
Primary
Cinacalcet Dose
Cinacalcet dose at Month 6
Time frame: Month 6
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Cinacalcet Dose | 48.9 mg/day | 95% Confidence Interval 0.9 |
Primary
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at initiation of treatment
Time frame: Initiation of treatment
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Cinacalcet Dosing Frequency | Once a day | 169 Participants | 0.9 |
| Cinacalcet | Cinacalcet Dosing Frequency | Twice a day | 134 Participants | — |
Primary
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 12
Time frame: Month 12
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Cinacalcet Dosing Frequency | Other | 4 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Once a day | 121 Participants | 0.9 |
| Cinacalcet | Cinacalcet Dosing Frequency | Twice a day | 88 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Three times a day | 6 Participants | — |
Primary
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 6
Time frame: Month 6
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Cinacalcet Dosing Frequency | Once a day | 128 Participants | 0.9 |
| Cinacalcet | Cinacalcet Dosing Frequency | Twice a day | 94 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Three times a day | 4 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Dose withheld | 3 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Other | 4 Participants | — |
Primary
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 3
Time frame: Month 3
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Cinacalcet Dosing Frequency | Once a day | 133 Participants | 0.9 |
| Cinacalcet | Cinacalcet Dosing Frequency | Twice a day | 107 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Three times a day | 4 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Four times a day | 1 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Dose withheld | 6 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Other | 4 Participants | — |
Primary
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at end of treatment
Time frame: Up to Month 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Cinacalcet Dosing Frequency | Once a day | 168 Participants | 0.9 |
| Cinacalcet | Cinacalcet Dosing Frequency | Twice a day | 118 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Three times a day | 10 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Four times a day | 3 Participants | — |
| Cinacalcet | Cinacalcet Dosing Frequency | Other | 4 Participants | — |
Primary
Duration of Exposure to Cinacalcet
Time from first dose to last non-zero dose on study
Time frame: 12 months
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Duration of Exposure to Cinacalcet | 366 Days | Inter-Quartile Range 7.3 |
Primary
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12
Time frame: Month 12
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12 | Yes | 105 Participants | 0.9 |
| Cinacalcet | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12 | No | 43 Participants | — |
Primary
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3
Time frame: Month 3
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3 | Yes | 138 Participants | 0.9 |
| Cinacalcet | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3 | No | 82 Participants | — |
Primary
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6
Time frame: Month 6
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6 | Yes | 134 Participants | 0.9 |
| Cinacalcet | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6 | No | 59 Participants | — |
Primary
Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation
Time frame: >3 to 6 months after initiation
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation | Yes | 45 Participants | 0.9 |
| Cinacalcet | Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation | No | 210 Participants | — |
Primary
Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation
Time frame: >6 months after initiation
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation | No | 182 Participants | — |
| Cinacalcet | Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation | Yes | 51 Participants | 0.9 |
Primary
Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation
Time frame: Initiation to Month 3
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation | Yes | 100 Participants | 0.9 |
| Cinacalcet | Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation | No | 203 Participants | — |
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
Time frame: Baseline to Month 12
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | 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 |
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
Time frame: Baseline to Month 12
Population: Full Analysis Set - Participants with Observed Data
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | 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 |
Primary
Reason for Prescribing Cinacalcet
Time frame: Initiation
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cinacalcet | Reason for Prescribing Cinacalcet | Surgery not considered appropriate by physician | 107 Participants | — |
| Cinacalcet | Reason for Prescribing Cinacalcet | Other | 1 Participants | — |
| Cinacalcet | Reason for Prescribing Cinacalcet | Failed surgery | 33 Participants | 0.9 |
| Cinacalcet | Reason for Prescribing Cinacalcet | Surgery contraindicated | 33 Participants | — |
| Cinacalcet | Reason for Prescribing Cinacalcet | Reduction of hypercalcaemia before surgery | 43 Participants | — |
| Cinacalcet | Reason for Prescribing Cinacalcet | Surgery declined by patient | 86 Participants | — |