Trial Outcomes & Findings for Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease (NCT NCT00261950)
NCT ID: NCT00261950
Last Updated: 2014-07-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Baseline to week 52
Results posted on
2014-07-21
Participant Flow
May 22 2006 is study initiation date and 13 May 2011 is study completion date.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
6
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Other
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Protocol specified Criteria
|
11
|
Baseline Characteristics
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Baseline characteristics by cohort
| Measure |
Cinacalcet
n=110 Participants
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.
|
|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 14.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
91 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with bone biopsy at week 52
Outcome measures
| Measure |
Cinacalcet
n=77 Participants
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.
|
|---|---|
|
Change From Baseline to End of Study in Bone Formation Rate (BFR)
|
-488 μm^2/mm^2/day
Standard Error 73
|
SECONDARY outcome
Timeframe: Baseline to weeks 40-52Population: Enrolled subjects with serum calcium during the Efficacy Assessment Phase (EAP)
Outcome measures
| Measure |
Cinacalcet
n=74 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)
|
-6.5 percent change
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline to weeks 40-52Population: Enrolled subjects with serum phosphorus during the Efficacy Assessment Phase (EAP)
Outcome measures
| Measure |
Cinacalcet
n=74 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)
|
-1.1 percent change
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline to weeks 40-52Population: Enrolled subjects with Ca x P during the Efficacy Assessment Phase (EAP)
Outcome measures
| Measure |
Cinacalcet
n=74 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)
|
-6.9 percent change
Standard Error 3.1
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with BALP at week 52
Outcome measures
| Measure |
Cinacalcet
n=73 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52
|
6.6 percent change
Standard Error 12.7
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with NTx at week 52
Outcome measures
| Measure |
Cinacalcet
n=72 Participants
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.
|
|---|---|
|
Percent Change From Baseline in N - Telopeptide (NTx) at Week 52
|
-14.0 percent change
Standard Error 14.7
|
SECONDARY outcome
Timeframe: Baseline to weeks 40-52Population: Enrolled subjects with PTH during the Efficacy Assessment Phase (EAP)
Outcome measures
| Measure |
Cinacalcet
n=74 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)
|
-41.6 percent change
Standard Error 4.4
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with Osteoblast Perimeter at week 52
Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter \* 100"
Outcome measures
| Measure |
Cinacalcet
n=77 Participants
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.
|
|---|---|
|
Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)
|
-4.3 percentage of osteoid perimeter
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with Osteoclast Perimeter at week 52
Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter \* 100"
Outcome measures
| Measure |
Cinacalcet
n=77 Participants
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.
|
|---|---|
|
Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)
|
-2.7 percentage of eroded perimeter
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with Fibrosis Area/Tissue Area at week 52
Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area \* 100)
Outcome measures
| Measure |
Cinacalcet
n=77 Participants
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.
|
|---|---|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 0% End of Study 0%
|
3 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 0% End of Study 1-5%
|
3 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 0% End of Study 6-10%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 0% End of Study 11-25%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 0% End of Study ≥ 26%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 1-5% End of Study 0%
|
17 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 1-5% End of Study 1-5%
|
31 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 1-5% End of Study 6-10%
|
2 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 1-5% End of Study 11-25%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 1-5% End of Study ≥ 26%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 6-10% End of Study 0%
|
4 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 6-10% End of Study 1-5%
|
7 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 6-10%% End of Study 6-10%
|
5 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 6-10% End of Study 11-25%
|
2 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 6-10% End of Study ≥ 26%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 11-25% End of Study 0%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 11-25% End of Study 1-5%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 11-25% End of Study 6-10%
|
1 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 11-25% End of Study 11-25%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline 11-25% End of Study ≥ 26%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline ≥ 26% End of Study 0%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline ≥ 26% End of Study 1-5%
|
1 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline ≥ 26% End of Study 6-10%
|
1 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline ≥ 26% End of Study 11-25%
|
0 participants
|
|
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Baseline ≥ 26% End of Study ≥ 26%
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with eroded perimeter/bone perimeter at week 52
Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter \* 100"
Outcome measures
| Measure |
Cinacalcet
n=77 Participants
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.
|
|---|---|
|
Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter
|
-3.4 percentage of bone perimeter
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with osteocalcin (OC) at week 52
Outcome measures
| Measure |
Cinacalcet
n=68 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Osteocalcin (OC) at Week 52
|
-21.8 Percent change
Standard Error 6.2
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: Enrolled subjects with TRAP at week 52
Outcome measures
| Measure |
Cinacalcet
n=71 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52
|
-3.8 percent change
Standard Error 9.2
|
Adverse Events
Cinacalcet
Serious events: 45 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cinacalcet
n=110 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Angina pectoris
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Angina unstable
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bradycardia
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
2.7%
3/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Myocardial ischaemia
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Diplopia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Papilloedema
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haematemesis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
2.7%
3/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Death
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Facial pain
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Impaired healing
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Acinetobacter infection
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Anal abscess
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Breast abscess
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Endocarditis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Escherichia infection
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gangrene
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infected skin ulcer
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infection
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Osteomyelitis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
2.7%
3/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Viral infection
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Wound infection
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood pressure increased
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
3/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Ataxia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dysarthria
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Presyncope
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Syncope
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Confusional state
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression suicidal
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Haematuria
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal pain
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
3/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Arterial disorder
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Arteriovenous fistula
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Peripheral ischaemia
|
0.91%
1/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Peripheral vascular disorder
|
1.8%
2/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Cinacalcet
n=110 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
7/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.3%
8/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
22/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
9/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
25.5%
28/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
20.9%
23/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
5.5%
6/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
5.5%
6/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
7.3%
8/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
6/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.3%
8/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.3%
8/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
11/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
13/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
9/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.9%
12/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
7/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
7.3%
8/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
6.4%
7/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
7/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
10/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
7.3%
8/110 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
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 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.
- Publication restrictions are in place
Restriction type: OTHER