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| ID | Type | Description | Link |
|---|---|---|---|
| PRIMARA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinacalcet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinacalcet | Drug |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with primary HPT receiving cinacalcet in clinical practice
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22566664 | Background | 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. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cinacalcet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cinacalcet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cinacalcet Dose | Cinacalcet dose at initiation of treatment | Full Analysis Set | Posted | Mean | 95% Confidence Interval | mg/day | Initiation of treatment |
|
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cinacalcet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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 |
| Lost to Follow-up |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
| Primary | Cinacalcet Dose | Cinacalcet dose at Month 3 | Full Analysis Set - Participants with Observed Data | Posted | Mean | 95% Confidence Interval | mg/day | Month 3 |
|
|
|
| Primary | Cinacalcet Dose | Cinacalcet dose at Month 6 | Full Analysis Set - Participants with Observed Data | Posted | Mean | 95% Confidence Interval | mg/day | Month 6 |
|
|
|
| Primary | Cinacalcet Dose | Cinacalcet dose at Month 12 | Full Analysis Set - Participants with Observed Data | Posted | Mean | 95% Confidence Interval | mg/day | Month 12 |
|
|
|
| Primary | Cinacalcet Dose | Cinacalcet dose at end of treatment (last dose received) | Full Analysis Set | Posted | Mean | 95% Confidence Interval | mg/day | Up to Month 12 |
|
|
|
| Primary | Cinacalcet Dosing Frequency | Cinacalcet dosing frequency at initiation of treatment | Full Analysis Set | Posted | Number | Participants | Initiation of treatment |
|
|
|
| Primary | Cinacalcet Dosing Frequency | Cinacalcet dosing frequency at Month 3 | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | Month 3 |
|
|
|
| Primary | Cinacalcet Dosing Frequency | Cinacalcet dosing frequency at Month 6 | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | Month 6 |
|
|
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| Primary | Cinacalcet Dosing Frequency | Cinacalcet dosing frequency at Month 12 | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | Month 12 |
|
|
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| Primary | Cinacalcet Dosing Frequency | Cinacalcet dosing frequency at end of treatment | Full Analysis Set | Posted | Number | Participants | Up to Month 12 |
|
|
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| Primary | Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation | Full Analysis Set | Posted | Number | Participants | Initiation to Month 3 |
|
|
|
| Primary | Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | >3 to 6 months after initiation |
|
|
|
| Primary | Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | >6 months after initiation |
|
|
|
| Primary | Duration of Exposure to Cinacalcet | Time from first dose to last non-zero dose on study | Full Analysis Set | Posted | Median | Inter-Quartile Range | Days | 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. | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | 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. | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | 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. | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | Month 12 |
|
|
|
| Primary | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3 | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | Month 3 |
|
|
|
| Primary | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6 | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | Month 6 |
|
|
|
| Primary | Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12 | Full Analysis Set - Participants with Observed Data | Posted | Number | Participants | Month 12 |
|
|
|
| Primary | Change From Baseline to Month 3 in Albumin-corrected Serum Calcium | Full Analysis Set - Participants with Observed Data | Posted | Mean | Standard Error | mmol/L | Baseline to Month 3 |
|
|
|
| Primary | Change From Baseline to Month 6 in Albumin-corrected Serum Calcium | Full Analysis Set - Participants with Observed Data | Posted | Mean | Standard Error | mmol/L | Baseline to Month 6 |
|
|
|
| Primary | Change From Baseline to Month 12 in Albumin-corrected Serum Calcium | Full Analysis Set - Participants with Observed Data | Posted | Mean | Standard Error | mmol/L | 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 | Full Analysis Set - Participants with Observed Data | Posted | Median | Inter-Quartile Range | Percent change | 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 | Full Analysis Set - Participants with Observed Data | Posted | Median | Inter-Quartile Range | Percent change | Baseline to Month 12 |
|
|
|
| Primary | Reason for Prescribing Cinacalcet | Full Analysis Set | Posted | Number | Participants | Initiation |
|
|
|
| 2 |
| 303 |
| 41 |
| 303 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
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.
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |