Trial Outcomes & Findings for Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis (NCT NCT01674621)
NCT ID: NCT01674621
Last Updated: 2020-06-16
Results Overview
Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
Baseline, 6 Months
Results posted on
2020-06-16
Participant Flow
Participant milestones
| Measure |
Abaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
Abaloparatide-Subcutaneous (SC) Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
48
|
51
|
50
|
|
Overall Study
Modified Intent-to-Treat Population
|
47
|
46
|
43
|
49
|
46
|
|
Overall Study
Safety Population
|
50
|
51
|
47
|
51
|
50
|
|
Overall Study
COMPLETED
|
45
|
43
|
41
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
7
|
6
|
6
|
Reasons for withdrawal
| Measure |
Abaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
Abaloparatide-Subcutaneous (SC) Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
5
|
5
|
1
|
|
Overall Study
Inability to Complete Study Procedures
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Severe Abaloparatide-SC Hypersensitivity
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
2
|
0
|
1
|
|
Overall Study
Other than specified
|
0
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 4.83 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 5.26 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 6.46 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 5.48 • n=4 Participants
|
66.5 years
STANDARD_DEVIATION 7.27 • n=21 Participants
|
66.2 years
STANDARD_DEVIATION 5.87 • n=8 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
231 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
|
PRIMARY outcome
Timeframe: Baseline, 6 MonthsPopulation: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
|
1.87 Percent change
Standard Deviation 2.87
|
2.33 Percent change
Standard Deviation 2.96
|
2.95 Percent change
Standard Deviation 3.13
|
5.80 Percent change
Standard Deviation 4.21
|
0.04 Percent change
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: mITT population included all participants with pre-treatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Percent change in BMD as specified by DXA scans of the total hip.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in BMD of Total Hip at 6 Months
|
0.97 Percent change
Standard Deviation 1.95
|
1.32 Percent change
Standard Deviation 1.96
|
1.49 Percent change
Standard Deviation 1.73
|
2.74 Percent change
Standard Deviation 3.05
|
-0.02 Percent change
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Percent change in BMD as specified by DXA scans of the forearm.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in BMD of Forearm at 6 Months
|
-0.24 Percent change
Standard Deviation 2.74
|
-0.16 Percent change
Standard Deviation 3.71
|
0.84 Percent change
Standard Deviation 2.96
|
0.33 Percent change
Standard Deviation 3.41
|
0.05 Percent change
Standard Deviation 3.18
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
|
-4.84 Percent change
Standard Deviation 23.87
|
5.22 Percent change
Standard Deviation 43.66
|
-5.52 Percent change
Standard Deviation 37.86
|
17.30 Percent change
Standard Deviation 42.76
|
10.23 Percent change
Standard Deviation 64.93
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
|
-17.26 Percent change
Standard Deviation 22.86
|
-8.42 Percent change
Standard Deviation 29.51
|
-16.63 Percent change
Standard Deviation 25.11
|
10.28 Percent change
Standard Deviation 72.31
|
-6.76 Percent change
Standard Deviation 31.35
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Osteocalcin at 6 Months
|
-4.37 Percent change
Standard Deviation 19.36
|
6.67 Percent change
Standard Deviation 33.38
|
-3.83 Percent change
Standard Deviation 22.01
|
69.54 Percent change
Standard Deviation 81.79
|
-4.21 Percent change
Standard Deviation 27.55
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
|
-12.76 Percent change
Standard Deviation 26.81
|
1.52 Percent change
Standard Deviation 57.29
|
-6.78 Percent change
Standard Deviation 38.91
|
97.64 Percent change
Standard Deviation 172.52
|
-7.26 Percent change
Standard Deviation 35.49
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=43 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=49 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=46 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
|
-2.61 Percent change
Standard Deviation 28.77
|
1.65 Percent change
Standard Deviation 48.66
|
-8.22 Percent change
Standard Deviation 54.84
|
41.11 Percent change
Standard Deviation 104.12
|
9.42 Percent change
Standard Deviation 22.57
|
SECONDARY outcome
Timeframe: Baseline up to 6 MonthsPopulation: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=51 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=51 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Skin at Screening
|
28 Participants
|
24 Participants
|
17 Participants
|
14 Participants
|
21 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Head at Screening
|
6 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Head at 6 months
|
6 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Extremities at 6 months
|
23 Participants
|
10 Participants
|
14 Participants
|
25 Participants
|
21 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Neurologic at Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Neurologic at 6 months
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
General appearance at Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
General appearance at 6 months
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Skin at 6 months
|
29 Participants
|
26 Participants
|
16 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Lungs at Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Lungs at 6 months
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Breasts at Screening
|
4 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Breasts at 6 months
|
4 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Abdomen at Screening
|
7 Participants
|
8 Participants
|
4 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Abdomen at 6 months
|
6 Participants
|
7 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Lymph nodes at Screening
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Lymph nodes at 6 months
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Columna at Screening
|
1 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Columna at 6 months
|
1 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Extremities at Screening
|
21 Participants
|
13 Participants
|
14 Participants
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 7 MonthsPopulation: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=51 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=51 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Hypertension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Blood Pressure Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Heart Rate increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Dyspnoea
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 7 MonthsPopulation: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=51 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=51 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 6 MonthsPopulation: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9\*10\^9/liter \[L\]; Grade 4 \<1.0\*10\^9/L), platelets (Grade 3: 25.0-49.9\*10\^9/L; Grade 4: \<25.0\*10\^9/L), haemoglobin (Grade 3: 65.0-79.0 grams \[g\]/L or 4.0-4.9 mmol/L; Grade 4: \<65.0 g/L or \<4.0 millimole \[mmol\]/L), granulocytes/bands (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5\*10\^9/L), lymphocytes (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5 \*10\^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, \> 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=51 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=51 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
|
6 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 6 MonthsPopulation: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), \>1.0 g%, or \>10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0\*normal; Grade 4: \>6.0\*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units \[U\]/L\*normal, Grade 4: \>20.0 U/L\*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), total bilirubin (Grade 3: 1.5-3.0\*normal; Grade 4: \>3.0\*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=51 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=51 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 6 MonthsPopulation: Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%\*normal, Grade 4: \>2.00%\*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds \[sec\], Grade 4: \>3.00 secs\*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Abaloparatide Transdermal (50 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=51 Participants
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=47 Participants
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=51 Participants
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=50 Participants
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Abaloparatide Transdermal (50 mcg)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Abaloparatide Transdermal (100 mcg)
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Abaloparatide Transdermal (150 mcg)
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Abaloparatide Injection (80 mcg)
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Abaloparatide Transdermal Placebo (0 mcg)
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abaloparatide Transdermal (50 mcg)
n=50 participants at risk
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=51 participants at risk
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=47 participants at risk
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=51 participants at risk
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=50 participants at risk
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.1%
1/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.1%
1/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
Other adverse events
| Measure |
Abaloparatide Transdermal (50 mcg)
n=50 participants at risk
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (100 mcg)
n=51 participants at risk
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
|
Abaloparatide Transdermal (150 mcg)
n=47 participants at risk
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
|
Abaloparatide Injection (80 mcg)
n=51 participants at risk
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
|
Abaloparatide Transdermal Placebo (0 mcg)
n=50 participants at risk
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
3.9%
2/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
4/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
6.4%
3/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
12.8%
6/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
4.0%
2/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
General disorders
Application site erythema
|
8.0%
4/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
9.8%
5/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
8.5%
4/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
4.0%
2/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
General disorders
Application site pruritus
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
8.5%
4/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
General disorders
Influenza like illness
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.1%
1/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
4.0%
2/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
8.5%
4/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Infections and infestations
Cystitis
|
4.0%
2/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
8.5%
4/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Infections and infestations
Influenza
|
8.0%
4/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
7.8%
4/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
4.3%
2/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
9.8%
5/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
8.0%
4/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Infections and infestations
Nasopharyngitis
|
22.0%
11/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
19.6%
10/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
17.0%
8/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
25.5%
13/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
18.0%
9/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.0%
3/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.1%
1/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
4.0%
2/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
8.5%
4/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
6.0%
3/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
7.8%
4/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
6.4%
3/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
10.0%
5/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
3.9%
2/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
6.4%
3/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
15.7%
8/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
3.9%
2/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
10.6%
5/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
9.8%
5/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
10.0%
5/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Renal and urinary disorders
Hypercalciuria
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
4.3%
2/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
6.0%
3/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
3/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
6.4%
3/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
General disorders
Injection site erythema
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
0.00%
0/47 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
5.9%
3/51 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
2.0%
1/50 • Baseline up to 7 Months
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/\> 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/\> 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.
- Publication restrictions are in place
Restriction type: OTHER