Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BONAFIDE Study | Other Identifier | Amgen | |
| IND #56,010 | Other Identifier | Food and Drug Administration |
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The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
Secondary hyperparathyroidism (HPT) is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone (PTH) levels . Patients with secondary HPT may have bone disease (osteodystrophy). Cinacalcet has been used to decrease PTH levels in patients with secondary HPT. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. The purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinacalcet | Experimental | All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensipar (Cinacalcet HCl) | Drug | All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Study in Bone Formation Rate (BFR) | Baseline to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | |
| Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 |
Not provided
Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria:
Exclusion Criteria: Subjects will be ineligible for the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85012 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | TBD.BONAFIDE Baseline/Primary Results.Journal-004521; | ||
| 25337774 | Background | Behets GJ, Spasovski G, Sterling LR, Goodman WG, Spiegel DM, De Broe ME, D'Haese PC. Bone histomorphometry before and after long-term treatment with cinacalcet in dialysis patients with secondary hyperparathyroidism. Kidney Int. 2015 Apr;87(4):846-56. doi: 10.1038/ki.2014.349. Epub 2014 Oct 22. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
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May 22 2006 is study initiation date and 13 May 2011 is study completion date.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cinacalcet | cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 |
| Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 | Baseline to week 52 |
| Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 | Baseline to week 52 |
| Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 |
| Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) | Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter * 100" | Baseline to week 52 |
| Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) | Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter * 100" | Baseline to week 52 |
| Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area | Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100) | Baseline to week 52 |
| Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter | Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter * 100" | Baseline to week 52 |
| Percent Change From Baseline in Osteocalcin (OC) at Week 52 | Baseline to week 52 |
| Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52 | Baseline to week 52 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Research Site | Denver | Colorado | 80220 | United States |
| Research Site | New Haven | Connecticut | 06511 | United States |
| Research Site | Fort Lauderdale | Florida | 33334 | United States |
| Research Site | Evanston | Illinois | 60201 | United States |
| Research Site | New Orleans | Louisiana | 70121 | United States |
| Research Site | Baltimore | Maryland | 21205 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Teaneck | New Jersey | 07666 | United States |
| Research Site | Flushing | New York | 11355 | United States |
| Research Site | Great Neck | New York | 11021 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | The Bronx | New York | 10467 | United States |
| Research Site | Allentown | Pennsylvania | 18103 | United States |
| Research Site | Houston | Texas | 77076 | United States |
| Research Site | Antwerp | 2020 | Belgium |
| Research Site | Antwerp | 2060 | Belgium |
| Research Site | Brussels | 1070 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | Prague | 169 00 | Czechia |
| Research Site | Budapest | 1083 | Hungary |
| Research Site | Debrecen | 4012 | Hungary |
| Research Site | Győr | 9023 | Hungary |
| Research Site | Miskolc | 3526 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Avellino | 83100 | Italy |
| Research Site | Cremona | 26100 | Italy |
| Research Site | Genova | 16132 | Italy |
| Research Site | Milan | 20162 | Italy |
| Research Site | Ortona CH | 66026 | Italy |
| Research Site | Ostia RM | 00122 | Italy |
| Research Site | Roma | 00149 | Italy |
| Research Site | Roma | 00184 | Italy |
| Research Site | Roma (RM) | 00133 | Italy |
| Research Site | Skopje | 1000 | North Macedonia |
| Research Site | Krakow | 31-501 | Poland |
| Research Site | Lodz | 90-153 | Poland |
| Research Site | Wroclaw | 50-556 | Poland |
| Research Site | Porto | PR | 4250-499 | Portugal |
| Research Site | Almada | 2800-455 | Portugal |
| Research Site | Estoril | 2765-294 | Portugal |
| Research Site | Guimarães | 4810-273 | Portugal |
| Research Site | Porto | 4200-072 | Portugal |
| Research Site | Vila Franca de Xira | 2600-076 | Portugal |
| Research Site | Santander | Cantabria | 39008 | Spain |
| Research Site | Barcelona | Cataluña | 08003 | Spain |
| Research Site | Barcelona | Cataluña | 08036 | Spain |
| Research Site | Alcorcón | Madrid | 28922 | Spain |
| Research Site | Madrid | Madrid | 28046 | Spain |
| Research Site | Zurich | 8091 | Switzerland |
| Research Site | Izmir | 35360 | Turkey (Türkiye) |
| Research Site | Manchester | M13 9WL | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cinacalcet | cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) | Enrolled subjects with serum calcium during the Efficacy Assessment Phase (EAP) | Posted | Mean | Standard Error | percent change | Baseline to weeks 40-52 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) | Enrolled subjects with serum phosphorus during the Efficacy Assessment Phase (EAP) | Posted | Mean | Standard Error | percent change | Baseline to weeks 40-52 |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) | Enrolled subjects with Ca x P during the Efficacy Assessment Phase (EAP) | Posted | Mean | Standard Error | percent change | Baseline to weeks 40-52 |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 | Enrolled subjects with BALP at week 52 | Posted | Mean | Standard Error | percent change | Baseline to week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 | Enrolled subjects with NTx at week 52 | Posted | Mean | Standard Error | percent change | Baseline to week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) | Enrolled subjects with PTH during the Efficacy Assessment Phase (EAP) | Posted | Mean | Standard Error | percent change | Baseline to weeks 40-52 |
|
| |||||||||||||||||||||||||||
| Primary | Change From Baseline to End of Study in Bone Formation Rate (BFR) | Enrolled subjects with bone biopsy at week 52 | Posted | Mean | Standard Error | μm^2/mm^2/day | Baseline to week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) | Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter * 100" | Enrolled subjects with Osteoblast Perimeter at week 52 | Posted | Mean | Standard Error | percentage of osteoid perimeter | Baseline to week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) | Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter * 100" | Enrolled subjects with Osteoclast Perimeter at week 52 | Posted | Mean | Standard Error | percentage of eroded perimeter | Baseline to week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area | Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100) | Enrolled subjects with Fibrosis Area/Tissue Area at week 52 | Posted | Number | participants | Baseline to week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter | Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter * 100" | Enrolled subjects with eroded perimeter/bone perimeter at week 52 | Posted | Mean | Standard Error | percentage of bone perimeter | Baseline to week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Osteocalcin (OC) at Week 52 | Enrolled subjects with osteocalcin (OC) at week 52 | Posted | Mean | Standard Error | Percent change | Baseline to week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52 | Enrolled subjects with TRAP at week 52 | Posted | Mean | Standard Error | percent change | Baseline to week 52 |
|
|
52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cinacalcet | cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information. | 45 | 110 | 84 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arterial disorder | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
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