Trial Outcomes & Findings for Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product (NCT NCT02053753)
NCT ID: NCT02053753
Last Updated: 2017-12-29
Results Overview
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
146 participants
Primary outcome timeframe
Day 1 predose up to day 127
Results posted on
2017-12-29
Participant Flow
This study was conducted at 2 centers in the United States.
Participants were randomized in a 1:1 ratio to receive a single 120-mg dose of denosumab either as a 1.7 mL single injection of 70 mg/mL denosumab produced using the new CP4 process or as a 1.7 mL single injection of 70 mg/mL denosumab produced from the current CP2 process.
Participant milestones
| Measure |
Denosumab CP4
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
74
|
|
Overall Study
Received Treatment
|
71
|
71
|
|
Overall Study
COMPLETED
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Denosumab CP4
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Decision by Sponsor
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
Baseline characteristics by cohort
| Measure |
Denosumab CP4
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black (or African American)
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 participants
n=5 Participants
|
42 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
20 participants
n=5 Participants
|
23 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
51 participants
n=5 Participants
|
48 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 predose up to day 127Population: The pharmacokinetic (PK) concentration analysis set includes all participants who received denosumab and had at least one PK sample collected. Two participants were excluded from all PK analyses because insufficient samples were available (≥ 3 missing consecutive samples) for calculation of PK variables.
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
Outcome measures
| Measure |
Denosumab CP4
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=69 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Maximum Observed Drug Concentration (Cmax) of Denosumab
|
12.7 μg/mL
Standard Deviation 3.53
|
11.8 μg/mL
Standard Deviation 3.51
|
PRIMARY outcome
Timeframe: Day 1 predose up to day 127Population: The PK concentration analysis set; 2 participants were excluded from all PK analyses because insufficient samples were available for calculation of PK variables and a further 11 participants were excluded from the analysis of AUC0-18 weeks because all samples after week 16 were missing.
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
Outcome measures
| Measure |
Denosumab CP4
n=64 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=65 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Area Under the Drug Concentration-time Curve From Time 0 to 18 Weeks Post-dose (AUC0-18 Weeks) of Denosumab
|
579 day*μg/mL
Standard Deviation 190
|
555 day*μg/mL
Standard Deviation 166
|
SECONDARY outcome
Timeframe: Day 1 predose up to day 127Population: The pharmacokinetic (PK) concentration analysis set includes all participants who received denosumab and had at least one PK sample collected. Two participants were excluded from all PK analyses because insufficient samples were available (≥ 3 missing consecutive samples) for calculation of PK variables.
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
Outcome measures
| Measure |
Denosumab CP4
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=69 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Denosumab
|
6.9 days
Interval 2.0 to 14.0
|
7.0 days
Interval 3.0 to 21.0
|
SECONDARY outcome
Timeframe: Day 1 predose up to day 127Population: The PK concentration analysis set; 2 participants were excluded from all PK analyses because insufficient samples were available for calculation of PK variables and a further 11 participants were excluded from the analysis of T1/2 because all samples after week 16 were missing.
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
Outcome measures
| Measure |
Denosumab CP4
n=64 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=65 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Half-life (T1/2) of Denosumab
|
23.9 days
Standard Deviation 10.1
|
22.4 days
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Day 1 predose up to day 127Population: The pharmacodynamic (PD) analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected. Eleven participants were excluded from the analysis of AUEC0-18 weeks because no samples after week 16 were collected.
Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis. AUEC0-18 weeks was estimated using the linear-log trapezoidal method.
Outcome measures
| Measure |
Denosumab CP4
n=65 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=66 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Area Under the Serum C-telopeptide (CTX1) Percent Inhibition-Time Curve From Time 0 to 18 Weeks Post-dose (AUEC0-18 Weeks)
|
8380 day*percent inhibition
Standard Deviation 2050
|
8190 day*percent inhibition
Standard Deviation 2250
|
SECONDARY outcome
Timeframe: Day 1 predose up to day 127Population: The pharmacodynamic analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected.
Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis.
Outcome measures
| Measure |
Denosumab CP4
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Maximum Percent Inhibition (Imax) of Serum CTX1
|
69.8 percent inhibition
Standard Deviation 17.0
|
70.3 percent inhibition
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Day 1 predose up to day 127Population: The pharmacodynamic analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected.
Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis.
Outcome measures
| Measure |
Denosumab CP4
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Time to Reach Maximum Percent Inhibition (Tmax) of Serum CTX1
|
3.01 days
Interval 0.0 to 112.0
|
3.96 days
Interval 1.0 to 126.0
|
SECONDARY outcome
Timeframe: From the first dose of denosumab through day 126Population: All participants who received denosumab
A treatment-related adverse event (TRAE) is any treatment-emergent adverse event (AE) that per investigator review has a reasonable possibility of being caused by the investigational product.
Outcome measures
| Measure |
Denosumab CP4
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Number of Participants With Adverse Events
Treatment-related fatal adverse events
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Any adverse event
|
26 participants
|
24 participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events
AEs leading to discontinuation of denosumab
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events (TRAEs)
|
4 participants
|
6 participants
|
|
Number of Participants With Adverse Events
Treatment-related serious adverse events
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
TRAEs leading to discontinuation of denosumab
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose on day 1, and days 29, 67 and 127Population: All participants who received denosumab
Outcome measures
| Measure |
Denosumab CP4
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=71 Participants
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Number of Participants Who Developed Anti-denosumab Antibodies
|
0 participants
|
0 participants
|
Adverse Events
Denosumab CP4
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Denosumab CP2
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Denosumab CP4
n=71 participants at risk
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=71 participants at risk
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Denosumab CP4
n=71 participants at risk
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
|
Denosumab CP2
n=71 participants at risk
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
|
|---|---|---|
|
Endocrine disorders
Goitre
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye pruritus
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Scleral discolouration
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Tooth loss
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site reaction
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vessel puncture site haematoma
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Conjunctivitis viral
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
2/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
2/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
2/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood calcium decreased
|
2.8%
2/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
2/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood phosphorus decreased
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
2/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
2/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
8.5%
6/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
4/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/71 • From the first dose of denosumab through day 126
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER