Trial Outcomes & Findings for A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women (NCT NCT01101061)
NCT ID: NCT01101061
Last Updated: 2019-07-31
Results Overview
A serious adverse event (SAE) is defined as an adverse event that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.
Results posted on
2019-07-31
Participant Flow
This study was conducted at 2 study centers in the United States. Eligible participants were healthy, postmenopausal first, second, or third generation Japanese women and non-Japanese women residing in the United States.
Participants were assigned to one of 4 cohorts. In 3 of the cohorts Japanese women were randomized in a 3:1 ratio to receive 1, 3, or 5 mg/kg romosozumab or placebo. In a 4th cohort non-Japanese women were randomized in a 2:1 ratio to receive 3 mg/kg romosozumab or placebo.
Participant milestones
| Measure |
Japanese Women: Placebo
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
6
|
2
|
4
|
|
Overall Study
Received Study Drug
|
6
|
6
|
6
|
6
|
2
|
4
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Japanese Women: Placebo
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
Baseline characteristics by cohort
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 Participants
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 Participants
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
57.5 years
STANDARD_DEVIATION 3.5 • n=21 Participants
|
55.0 years
STANDARD_DEVIATION 4.8 • n=8 Participants
|
59.5 years
STANDARD_DEVIATION 5.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.Population: All treated participants
A serious adverse event (SAE) is defined as an adverse event that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 Participants
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 Participants
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
6 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
AEs leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo)Population: All treated participants
Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 Participants
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 Participants
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Anti-romosozumab Binding Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85Population: All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 Participants
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 Participants
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Serum Calcium Levels
Day 8
|
2.39 mmol/L
Standard Error 0.05
|
2.25 mmol/L
Standard Error 0.02
|
2.31 mmol/L
Standard Error 0.03
|
2.29 mmol/L
Standard Error 0.03
|
2.35 mmol/L
Standard Error 0.00
|
2.38 mmol/L
Standard Error 0.03
|
|
Serum Calcium Levels
Baseline
|
2.34 mmol/L
Standard Error 0.04
|
2.31 mmol/L
Standard Error 0.04
|
2.33 mmol/L
Standard Error 0.03
|
2.38 mmol/L
Standard Error 0.03
|
2.28 mmol/L
Standard Error 0.08
|
2.45 mmol/L
Standard Error 0.04
|
|
Serum Calcium Levels
Day 2
|
2.33 mmol/L
Standard Error 0.04
|
2.34 mmol/L
Standard Error 0.03
|
2.31 mmol/L
Standard Error 0.03
|
2.36 mmol/L
Standard Error 0.03
|
2.34 mmol/L
Standard Error 0.04
|
2.40 mmol/L
Standard Error 0.05
|
|
Serum Calcium Levels
Day 3
|
2.33 mmol/L
Standard Error 0.05
|
2.36 mmol/L
Standard Error 0.04
|
2.31 mmol/L
Standard Error 0.03
|
2.38 mmol/L
Standard Error 0.03
|
2.34 mmol/L
Standard Error 0.01
|
2.43 mmol/L
Standard Error 0.03
|
|
Serum Calcium Levels
Day 4
|
2.32 mmol/L
Standard Error 0.05
|
2.31 mmol/L
Standard Error 0.03
|
2.30 mmol/L
Standard Error 0.03
|
2.32 mmol/L
Standard Error 0.03
|
2.38 mmol/L
Standard Error 0.02
|
2.36 mmol/L
Standard Error 0.04
|
|
Serum Calcium Levels
Day 6
|
2.39 mmol/L
Standard Error 0.05
|
2.30 mmol/L
Standard Error 0.03
|
2.31 mmol/L
Standard Error 0.04
|
2.35 mmol/L
Standard Error 0.04
|
2.28 mmol/L
Standard Error 0.02
|
2.40 mmol/L
Standard Error 0.03
|
|
Serum Calcium Levels
Day 12
|
2.35 mmol/L
Standard Error 0.06
|
2.27 mmol/L
Standard Error 0.05
|
2.33 mmol/L
Standard Error 0.03
|
2.28 mmol/L
Standard Error 0.02
|
2.33 mmol/L
Standard Error 0.03
|
2.28 mmol/L
Standard Error 0.04
|
|
Serum Calcium Levels
Day 22
|
2.31 mmol/L
Standard Error 0.03
|
2.31 mmol/L
Standard Error 0.03
|
2.28 mmol/L
Standard Error 0.05
|
2.25 mmol/L
Standard Error 0.03
|
2.33 mmol/L
Standard Error 0.00
|
2.36 mmol/L
Standard Error 0.03
|
|
Serum Calcium Levels
Day 29
|
2.37 mmol/L
Standard Error 0.03
|
2.30 mmol/L
Standard Error 0.04
|
2.28 mmol/L
Standard Error 0.03
|
2.30 mmol/L
Standard Error 0.02
|
2.36 mmol/L
Standard Error 0.04
|
2.38 mmol/L
Standard Error 0.05
|
|
Serum Calcium Levels
Day 43
|
2.35 mmol/L
Standard Error 0.04
|
2.33 mmol/L
Standard Error 0.03
|
2.28 mmol/L
Standard Error 0.03
|
2.34 mmol/L
Standard Error 0.04
|
2.30 mmol/L
Standard Error 0.07
|
2.34 mmol/L
Standard Error 0.01
|
|
Serum Calcium Levels
Day 57
|
2.37 mmol/L
Standard Error 0.03
|
2.32 mmol/L
Standard Error 0.04
|
2.29 mmol/L
Standard Error 0.04
|
2.30 mmol/L
Standard Error 0.03
|
2.28 mmol/L
Standard Error 0.00
|
2.31 mmol/L
Standard Error 0.02
|
|
Serum Calcium Levels
Day 71
|
2.34 mmol/L
Standard Error 0.01
|
—
|
—
|
2.39 mmol/L
Standard Error 0.02
|
—
|
—
|
|
Serum Calcium Levels
Day 85
|
2.29 mmol/L
Standard Error 0.01
|
—
|
—
|
2.35 mmol/L
Standard Error 0.02
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85Population: All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 Participants
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 Participants
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Baseline
|
4.47 pmol/L
Standard Error 0.97
|
4.24 pmol/L
Standard Error 0.70
|
4.93 pmol/L
Standard Error 0.84
|
3.63 pmol/L
Standard Error 0.62
|
3.77 pmol/L
Standard Error 1.65
|
2.73 pmol/L
Standard Error 0.37
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 2
|
4.51 pmol/L
Standard Error 0.78
|
4.92 pmol/L
Standard Error 0.78
|
5.01 pmol/L
Standard Error 0.47
|
4.23 pmol/L
Standard Error 0.54
|
3.50 pmol/L
Standard Error 1.49
|
2.57 pmol/L
Standard Error 0.23
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 3
|
4.93 pmol/L
Standard Error 0.71
|
4.69 pmol/L
Standard Error 0.69
|
5.38 pmol/L
Standard Error 0.44
|
4.58 pmol/L
Standard Error 0.76
|
3.50 pmol/L
Standard Error 1.06
|
2.89 pmol/L
Standard Error 0.37
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 4
|
4.47 pmol/L
Standard Error 0.84
|
5.09 pmol/L
Standard Error 0.69
|
5.09 pmol/L
Standard Error 0.23
|
5.20 pmol/L
Standard Error 1.13
|
3.93 pmol/L
Standard Error 1.70
|
3.55 pmol/L
Standard Error 0.73
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 6
|
4.21 pmol/L
Standard Error 0.67
|
4.97 pmol/L
Standard Error 0.93
|
5.75 pmol/L
Standard Error 0.72
|
4.44 pmol/L
Standard Error 0.77
|
3.82 pmol/L
Standard Error 1.49
|
3.66 pmol/L
Standard Error 0.66
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 8
|
4.19 pmol/L
Standard Error 0.95
|
5.91 pmol/L
Standard Error 0.86
|
5.23 pmol/L
Standard Error 0.68
|
4.79 pmol/L
Standard Error 0.90
|
4.14 pmol/L
Standard Error 1.91
|
3.98 pmol/L
Standard Error 0.68
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 12
|
5.04 pmol/L
Standard Error 0.95
|
6.42 pmol/L
Standard Error 0.59
|
5.46 pmol/L
Standard Error 0.41
|
5.80 pmol/L
Standard Error 0.61
|
4.19 pmol/L
Standard Error 1.86
|
4.46 pmol/L
Standard Error 0.64
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 22
|
4.69 pmol/L
Standard Error 0.74
|
5.57 pmol/L
Standard Error 0.64
|
6.15 pmol/L
Standard Error 0.56
|
7.09 pmol/L
Standard Error 0.84
|
5.46 pmol/L
Standard Error 2.71
|
4.62 pmol/L
Standard Error 0.68
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 29
|
4.83 pmol/L
Standard Error 0.99
|
5.02 pmol/L
Standard Error 0.74
|
5.92 pmol/L
Standard Error 0.68
|
6.14 pmol/L
Standard Error 0.72
|
4.83 pmol/L
Standard Error 2.81
|
4.43 pmol/L
Standard Error 0.40
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 43
|
4.61 pmol/L
Standard Error 0.89
|
6.03 pmol/L
Standard Error 0.73
|
5.27 pmol/L
Standard Error 0.32
|
5.61 pmol/L
Standard Error 0.84
|
3.93 pmol/L
Standard Error 1.27
|
3.53 pmol/L
Standard Error 0.35
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 57
|
3.89 pmol/L
Standard Error 0.84
|
4.90 pmol/L
Standard Error 0.64
|
4.87 pmol/L
Standard Error 0.39
|
4.86 pmol/L
Standard Error 0.55
|
2.76 pmol/L
Standard Error 0.85
|
2.68 pmol/L
Standard Error 0.27
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 71
|
3.40 pmol/L
Standard Error 0.85
|
—
|
—
|
4.10 pmol/L
Standard Error 0.47
|
—
|
—
|
|
Serum Intact Parathyroid Hormone (iPTH) Levels
Day 85
|
3.02 pmol/L
Standard Error 0.80
|
—
|
—
|
3.82 pmol/L
Standard Error 0.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85Population: All treated participants
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 Participants
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 Participants
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
|
26.85 percent change
Standard Error 6.39
|
59.23 percent change
Standard Error 12.21
|
102.57 percent change
Standard Error 18.26
|
196.37 percent change
Standard Error 29.79
|
8.30 percent change
Standard Error 1.78
|
164.44 percent change
Standard Error 35.58
|
SECONDARY outcome
Timeframe: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85Population: All treated participants
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 Participants
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 Participants
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Maximum Percent Change From Baseline in Serum C-telopeptide (CTX)
|
-12.64 percent change
Standard Error 1.40
|
-16.19 percent change
Standard Error 7.36
|
-35.92 percent change
Standard Error 1.94
|
-39.17 percent change
Standard Error 5.13
|
-25.46 percent change
Standard Error 8.52
|
-43.32 percent change
Standard Error 9.96
|
SECONDARY outcome
Timeframe: Baseline and days 12, 29, 43, 57, 71, and 85Population: All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 Participants
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 Participants
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Sclerostin
Day 71
|
-39.80 percent change
Standard Error 3.87
|
—
|
—
|
997.02 percent change
Standard Error 532.06
|
—
|
—
|
|
Percent Change From Baseline in Sclerostin
Day 12
|
-3.78 percent change
Standard Error 3.72
|
6639.01 percent change
Standard Error 534.50
|
13749.61 percent change
Standard Error 1091.63
|
17028.81 percent change
Standard Error 1875.81
|
-17.95 percent change
Standard Error 6.38
|
14652.96 percent change
Standard Error 1349.38
|
|
Percent Change From Baseline in Sclerostin
Day 29
|
591.80 percent change
Standard Error 596.47
|
1602.70 percent change
Standard Error 231.77
|
7667.80 percent change
Standard Error 675.45
|
12723.54 percent change
Standard Error 2138.65
|
-14.54 percent change
Standard Error 1.78
|
9581.13 percent change
Standard Error 1283.73
|
|
Percent Change From Baseline in Sclerostin
Day 43
|
-15.43 percent change
Standard Error 11.39
|
467.07 percent change
Standard Error 55.62
|
3384.02 percent change
Standard Error 613.99
|
6844.74 percent change
Standard Error 1730.04
|
-9.35 percent change
Standard Error 4.59
|
4487.33 percent change
Standard Error 1771.30
|
|
Percent Change From Baseline in Sclerostin
Day 57
|
-17.89 percent change
Standard Error 11.96
|
167.37 percent change
Standard Error 28.33
|
911.23 percent change
Standard Error 156.09
|
2836.61 percent change
Standard Error 1109.97
|
-0.41 percent change
Standard Error 12.65
|
1826.83 percent change
Standard Error 917.98
|
|
Percent Change From Baseline in Sclerostin
Day 85
|
-27.41 percent change
Standard Error 2.02
|
—
|
—
|
415.38 percent change
Standard Error 243.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.Population: All treated participants who received romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=4 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration of Romosozumab
|
5.0 days
Interval 5.0 to 8.0
|
5.0 days
Interval 3.0 to 12.0
|
5.0 days
Interval 5.0 to 7.0
|
5.0 days
Interval 5.0 to 7.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.Population: All treated participants who received romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=4 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration of Romosozumab
|
4.06 µg/mL
Standard Deviation 1.45
|
17.1 µg/mL
Standard Deviation 4.7
|
33.8 µg/mL
Standard Deviation 8.1
|
18.6 µg/mL
Standard Deviation 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.Population: All treated participants who received romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=4 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab
|
64.0 µg*day/mL
Standard Deviation 27.0
|
344 µg*day/mL
Standard Deviation 90
|
804 µg*day/mL
Standard Deviation 320
|
412 µg*day/mL
Standard Deviation 136
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.Population: All treated participants who received romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=4 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab
|
64.7 µg*day/mL
Standard Deviation 26.8
|
347 µg*day/mL
Standard Deviation 90
|
806 µg*day/mL
Standard Deviation 323
|
421 µg*day/mL
Standard Deviation 147
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.Population: All treated participants who received romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=4 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Romosozumab
|
18.6 mL/day/kg
Standard Deviation 10.0
|
9.27 mL/day/kg
Standard Deviation 2.64
|
6.98 mL/day/kg
Standard Deviation 2.35
|
7.91 mL/day/kg
Standard Deviation 2.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.Population: All treated participants who received romosozumab with available T1/2,β data
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Outcome measures
| Measure |
Japanese Women: Placebo
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=1 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=2 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab
|
—
|
15.1 days
Standard Deviation NA
Could not be calculated for 1 participant
|
16.2 days
Standard Deviation 4.1
|
15.3 days
Standard Deviation 6.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.Population: All treated participants who received romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Outcome measures
| Measure |
Japanese Women: Placebo
n=6 Participants
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 Participants
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=4 Participants
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab
|
5.82 days
Standard Deviation 1.05
|
6.31 days
Standard Deviation 1.14
|
7.19 days
Standard Deviation 1.55
|
6.81 days
Standard Deviation 2.69
|
—
|
—
|
Adverse Events
Japanese Women: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Japanese Women: Romosozumab 1 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Japanese Women: Romosozumab 3 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Japanese Women: Romosozumab 5 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Non-Japanese Women: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-Japanese Women: Romosozumab 3 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Japanese Women: Placebo
n=6 participants at risk
Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Japanese Women: Romosozumab 1 mg/kg
n=6 participants at risk
Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 3 mg/kg
n=6 participants at risk
Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
Japanese Women: Romosozumab 5 mg/kg
n=6 participants at risk
Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.
|
Non-Japanese Women: Placebo
n=2 participants at risk
Non-Japanese participants received a single subcutaneous injection of placebo on day 1.
|
Non-Japanese Women: Romosozumab 3 mg/kg
n=4 participants at risk
Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site pruritus
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vessel puncture site haematoma
|
33.3%
2/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
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%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Venomous sting
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
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