Trial Outcomes & Findings for Phase 3 Clinical Trial of Teriparatide in Japan (NCT NCT00433160)
NCT ID: NCT00433160
Last Updated: 2010-09-21
Results Overview
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
207 participants
Primary outcome timeframe
Baseline to 52 weeks
Results posted on
2010-09-21
Participant Flow
Results from 4 patients aren't included in baseline and outcomes: 3 (2 placebo and 1 teriparatide) didn't receive study drug; 1 (placebo) had a significant good clinical practice issue of receiving study drug assigned to another patient.
Participant milestones
| Measure |
Teriparatide
20 micrograms for 104 weeks
|
Placebo
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
52-Week Double-Blind (DB) Period
STARTED
|
137
|
70
|
|
52-Week Double-Blind (DB) Period
Received Treatment
|
136
|
68
|
|
52-Week Double-Blind (DB) Period
COMPLETED
|
120
|
60
|
|
52-Week Double-Blind (DB) Period
NOT COMPLETED
|
17
|
10
|
|
76 Weeks, 24-Week Open Label (OL) Period
STARTED
|
119
|
59
|
|
76 Weeks, 24-Week Open Label (OL) Period
Received Treatment
|
119
|
59
|
|
76 Weeks, 24-Week Open Label (OL) Period
COMPLETED
|
113
|
55
|
|
76 Weeks, 24-Week Open Label (OL) Period
NOT COMPLETED
|
6
|
4
|
|
104 Weeks, 28-Week OL Period
STARTED
|
102
|
50
|
|
104 Weeks, 28-Week OL Period
Received Treatment
|
102
|
50
|
|
104 Weeks, 28-Week OL Period
COMPLETED
|
92
|
47
|
|
104 Weeks, 28-Week OL Period
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Teriparatide
20 micrograms for 104 weeks
|
Placebo
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
52-Week Double-Blind (DB) Period
Adverse Event
|
6
|
2
|
|
52-Week Double-Blind (DB) Period
Death
|
0
|
0
|
|
52-Week Double-Blind (DB) Period
Lost to Follow-up
|
0
|
0
|
|
52-Week Double-Blind (DB) Period
Entry Criteria Exclusion
|
0
|
1
|
|
52-Week Double-Blind (DB) Period
Protocol Violation
|
0
|
2
|
|
52-Week Double-Blind (DB) Period
Withdrawal by Subject
|
6
|
1
|
|
52-Week Double-Blind (DB) Period
Physician Decision
|
4
|
2
|
|
52-Week Double-Blind (DB) Period
Sponsor Decision
|
0
|
0
|
|
52-Week Double-Blind (DB) Period
Lack of Efficacy
|
1
|
2
|
|
76 Weeks, 24-Week Open Label (OL) Period
Adverse Event
|
3
|
1
|
|
76 Weeks, 24-Week Open Label (OL) Period
Withdrawal by Subject
|
1
|
2
|
|
76 Weeks, 24-Week Open Label (OL) Period
Physician Decision
|
2
|
0
|
|
76 Weeks, 24-Week Open Label (OL) Period
Lack of Efficacy
|
0
|
1
|
|
104 Weeks, 28-Week OL Period
Adverse Event
|
2
|
0
|
|
104 Weeks, 28-Week OL Period
Withdrawal by Subject
|
8
|
2
|
|
104 Weeks, 28-Week OL Period
Physician Decision
|
0
|
1
|
Baseline Characteristics
Phase 3 Clinical Trial of Teriparatide in Japan
Baseline characteristics by cohort
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
69.2 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
69.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
136 participants
n=5 Participants
|
67 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Alcohol Consumption
No
|
99 participants
n=5 Participants
|
51 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
Alcohol Consumption
Yes
|
37 participants
n=5 Participants
|
16 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Number of Previous Vertebral Fractures
0 Fractures
|
82 participants
n=5 Participants
|
38 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Number of Previous Vertebral Fractures
1 Fracture
|
35 participants
n=5 Participants
|
16 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Number of Previous Vertebral Fractures
2 Fractures
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Number of Previous Vertebral Fractures
3 Fractures
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Number of Previous Vertebral Fractures
4 Fractures
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of Previous Vertebral Fractures
5 or More Fractures
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Previous Osteoporosis Drug Use
No
|
86 participants
n=5 Participants
|
44 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Previous Osteoporosis Drug Use
Yes
|
50 participants
n=5 Participants
|
23 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Smoking History
Non-Smoker
|
114 participants
n=5 Participants
|
53 participants
n=7 Participants
|
167 participants
n=5 Participants
|
|
Smoking History
Past Smoker
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Smoking History
Current Smoker
|
16 participants
n=5 Participants
|
5 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Body Mass Index
|
21.58 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.03 • n=5 Participants
|
22.24 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.34 • n=7 Participants
|
21.80 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.15 • n=5 Participants
|
|
Bone Mineral Density (BMD) Total Spine
|
0.6153 grams per square centimeter (g/cm^2)
STANDARD_DEVIATION 0.0701 • n=5 Participants
|
0.6123 grams per square centimeter (g/cm^2)
STANDARD_DEVIATION 0.0780 • n=7 Participants
|
0.6143 grams per square centimeter (g/cm^2)
STANDARD_DEVIATION 0.0726 • n=5 Participants
|
|
Height
|
150.40 centimeters (cm)
STANDARD_DEVIATION 5.97 • n=5 Participants
|
150.30 centimeters (cm)
STANDARD_DEVIATION 5.74 • n=7 Participants
|
150.36 centimeters (cm)
STANDARD_DEVIATION 5.89 • n=5 Participants
|
|
Weight
|
48.74 kilograms (kg)
STANDARD_DEVIATION 6.83 • n=5 Participants
|
50.25 kilograms (kg)
STANDARD_DEVIATION 8.10 • n=7 Participants
|
49.24 kilograms (kg)
STANDARD_DEVIATION 7.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksPopulation: Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Outcome measures
| Measure |
Teriparatide
n=131 Participants
20 micrograms for 104 weeks
|
Placebo
n=63 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Percent Change to Last Measurement Point
|
9.82 percent change in BMD
Standard Deviation 5.36
|
0.04 percent change in BMD
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Outcome measures
| Measure |
Teriparatide
n=131 Participants
20 micrograms for 104 weeks
|
Placebo
n=63 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Percent Change to Last Measurement Point
|
10.23 percent change in BMD
Standard Deviation 5.74
|
0.11 percent change in BMD
Standard Deviation 4.42
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Outcome measures
| Measure |
Teriparatide
n=130 Participants
20 micrograms for 104 weeks
|
Placebo
n=62 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) at Total Hip
Percent Change to Last Measurement Point
|
2.66 percent change in BMD
Standard Deviation 4.22
|
-0.22 percent change in BMD
Standard Deviation 3.38
|
SECONDARY outcome
Timeframe: Baseline to 52 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Outcome measures
| Measure |
Teriparatide
n=130 Participants
20 micrograms for 104 weeks
|
Placebo
n=62 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Percent Change to Last Measurement Point
|
2.24 percent change in BMD
Standard Deviation 6.01
|
0.46 percent change in BMD
Standard Deviation 3.89
|
SECONDARY outcome
Timeframe: Baseline to Weeks 4, 12, 24, and 52Population: Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Percent Change to Week 4 (n=136, n=66)
|
90.67 percent change in PINP
Standard Deviation 49.85
|
-9.58 percent change in PINP
Standard Deviation 14.39
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Percent Change to Week 12 (n=131, n=64)
|
89.58 percent change in PINP
Standard Deviation 66.58
|
-16.89 percent change in PINP
Standard Deviation 17.35
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Percent Change to Week 24 (n=127, n=61)
|
114.12 percent change in PINP
Standard Deviation 112.04
|
-19.10 percent change in PINP
Standard Deviation 29.17
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Percent Change to Week 52 (n=121, n=60)
|
116.11 percent change in PINP
Standard Deviation 139.72
|
-14.18 percent change in PINP
Standard Deviation 29.02
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Percent Change to Last Measurement (n=136,n=66)
|
111.74 percent change in PINP
Standard Deviation 134.38
|
-13.82 percent change in PINP
Standard Deviation 28.42
|
SECONDARY outcome
Timeframe: Baseline to Weeks 4, 12, 24, 52Population: Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Percent Change to Week 4 (n=135, n=66)
|
3.74 percent change in BAP
Standard Deviation 37.86
|
-9.63 percent change in BAP
Standard Deviation 33.62
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Percent Change to Week 12 (n=131, n=62)
|
3.23 percent change in BAP
Standard Deviation 49.05
|
-16.97 percent change in BAP
Standard Deviation 40.54
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Percent Change to Week 24 (n=127, n=60)
|
-4.60 percent change in BAP
Standard Deviation 43.44
|
-28.46 percent change in BAP
Standard Deviation 23.81
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Percent Change to Week 52 (n=120, n=59)
|
-17.69 percent change in BAP
Standard Deviation 58.12
|
-32.24 percent change in BAP
Standard Deviation 46.95
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Percent Change to Last Measurement (n=136, n=66)
|
-17.32 percent change in BAP
Standard Deviation 56.06
|
-28.34 percent change in BAP
Standard Deviation 46.96
|
SECONDARY outcome
Timeframe: Baseline to Weeks 4, 12, 24, 52Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Percent Change to Week 4 (n=124, n=63)
|
2.78 percent change in CTX
Standard Deviation 40.73
|
-2.05 percent change in CTX
Standard Deviation 28.17
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Percent Change to Week 12 (n=121, n=61)
|
46.52 percent change in CTX
Standard Deviation 69.52
|
-3.56 percent change in CTX
Standard Deviation 27.90
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Percent Change to Week 24 (n=119, n=59)
|
82.27 percent change in CTX
Standard Deviation 110.54
|
4.39 percent change in CTX
Standard Deviation 37.97
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Percent Change to Week 52 (n=113, n=58)
|
84.81 percent change in CTX
Standard Deviation 124.23
|
13.50 percent change in CTX
Standard Deviation 39.47
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Percent Change to Last Measurement (n=126, n=65)
|
79.41 percent change in CTX
Standard Deviation 119.61
|
11.64 percent change in CTX
Standard Deviation 38.61
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures.
Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Vertebral Fractures by Central X-ray Assessment
New Fractures (n=5, n=4)
|
7 number of fractures
|
5 number of fractures
|
|
Vertebral Fractures by Central X-ray Assessment
Worsening Fractures (n=2, n=0)
|
3 number of fractures
|
0 number of fractures
|
SECONDARY outcome
Timeframe: Baseline through 52 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Fractures by Investigators Assessment
Vertebral Fracture - Fragility
|
0 number of fractures
|
1 number of fractures
|
|
Fractures by Investigators Assessment
Vertebral Fracture - Traumatic
|
0 number of fractures
|
0 number of fractures
|
|
Fractures by Investigators Assessment
Non-Vertebra Fracture - Traumatic
|
2 number of fractures
|
3 number of fractures
|
|
Fractures by Investigators Assessment
Non-Vertebra Fracture - Fragility
|
1 number of fractures
|
1 number of fractures
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 52Population: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Back Pain Severity
Baseline: 3 - Moderate
|
12 participants
|
4 participants
|
|
Back Pain Severity
Week 12: 2 - Mild
|
44 participants
|
18 participants
|
|
Back Pain Severity
Week 12: 3 - Moderate
|
8 participants
|
5 participants
|
|
Back Pain Severity
Week 12: 4 - Severe
|
0 participants
|
0 participants
|
|
Back Pain Severity
Week 24: 1 - None
|
87 participants
|
42 participants
|
|
Back Pain Severity
Week 24: 2 - Mild
|
34 participants
|
15 participants
|
|
Back Pain Severity
Week 24: 3 - Moderate
|
6 participants
|
4 participants
|
|
Back Pain Severity
Week 24: 4 - Severe
|
0 participants
|
0 participants
|
|
Back Pain Severity
Week 36: 1 - None
|
82 participants
|
42 participants
|
|
Back Pain Severity
Week 36: 2 - Mild
|
36 participants
|
15 participants
|
|
Back Pain Severity
Week 36: 3 - Moderate
|
5 participants
|
4 participants
|
|
Back Pain Severity
Week 36: 4 - Severe
|
0 participants
|
0 participants
|
|
Back Pain Severity
Week 52: 1 - None
|
84 participants
|
42 participants
|
|
Back Pain Severity
Week 52: 2 - Mild
|
32 participants
|
12 participants
|
|
Back Pain Severity
Week 52: 3 - Moderate
|
5 participants
|
5 participants
|
|
Back Pain Severity
Week 52: 4 - Severe
|
0 participants
|
1 participants
|
|
Back Pain Severity
Last Measurement: 1 - None
|
90 participants
|
44 participants
|
|
Back Pain Severity
Last Measurement: 2 - Mild
|
36 participants
|
14 participants
|
|
Back Pain Severity
Last Measurement: 3 - Moderate
|
5 participants
|
5 participants
|
|
Back Pain Severity
Last Measurement: 4 - Severe
|
0 participants
|
1 participants
|
|
Back Pain Severity
Baseline: 1 - None
|
77 participants
|
36 participants
|
|
Back Pain Severity
Baseline: 2 - Mild
|
47 participants
|
26 participants
|
|
Back Pain Severity
Baseline: 4 - Severe
|
0 participants
|
1 participants
|
|
Back Pain Severity
Week 12: 1 - None
|
79 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Baseline, 76 Weeks, 104 WeeksPopulation: Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Outcome measures
| Measure |
Teriparatide
n=131 Participants
20 micrograms for 104 weeks
|
Placebo
n=63 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 76; n=113, n=55
|
11.93 percent change in BMD
Standard Deviation 5.79
|
6.39 percent change in BMD
Standard Deviation 4.74
|
|
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 104; n=92, n=47
|
13.42 percent change in BMD
Standard Deviation 6.12
|
9.11 percent change in BMD
Standard Deviation 5.14
|
SECONDARY outcome
Timeframe: Baseline, 76 Weeks, 104 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Outcome measures
| Measure |
Teriparatide
n=131 Participants
20 micrograms for 104 weeks
|
Placebo
n=63 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 76; n=113, n=55
|
12.24 percent change in BMD
Standard Deviation 5.86
|
6.63 percent change in BMD
Standard Deviation 4.69
|
|
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 104; n=92, n=47
|
14.01 percent change in BMD
Standard Deviation 6.41
|
9.46 percent change in BMD
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: Baseline, 76 Weeks, 104 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Outcome measures
| Measure |
Teriparatide
n=130 Participants
20 micrograms for 104 weeks
|
Placebo
n=62 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 76; n=112, n=54
|
3.02 percent change in BMD
Standard Deviation 3.79
|
1.64 percent change in BMD
Standard Deviation 4.63
|
|
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 104; n=91, n=46
|
3.67 percent change in BMD
Standard Deviation 3.98
|
2.46 percent change in BMD
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Baseline, 76 Weeks, 104 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Outcome measures
| Measure |
Teriparatide
n=130 Participants
20 micrograms for 104 weeks
|
Placebo
n=62 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 76; n=112, n=54
|
2.68 percent change in BMD
Standard Deviation 4.45
|
1.17 percent change in BMD
Standard Deviation 4.81
|
|
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 104; n=91, n=46
|
3.26 percent change in BMD
Standard Deviation 4.25
|
2.19 percent change in BMD
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: Baseline, 76 Weeks, 104 WeeksPopulation: Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change to Week 76; n=113, n=55
|
115.45 percent change in PINP
Standard Deviation 174.07
|
97.28 percent change in PINP
Standard Deviation 131.64
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change to Week 104; n=92, n=47
|
74.71 percent change in PINP
Standard Deviation 112.48
|
134.89 percent change in PINP
Standard Deviation 180.76
|
SECONDARY outcome
Timeframe: Baseline, 76 Weeks, 104 WeeksPopulation: Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 76; n=113, n=55
|
17.49 percent change in BAP
Standard Deviation 66.40
|
15.71 percent change in BAP
Standard Deviation 64.96
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 104; n=92, n=47
|
-1.52 percent change in BAP
Standard Deviation 54.38
|
16.45 percent change in BAP
Standard Deviation 71.72
|
SECONDARY outcome
Timeframe: Baseline, 76 Weeks, 104 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 76; n=104, n=53
|
85.85 percent change in CTX
Standard Deviation 137.13
|
86.98 percent change in CTX
Standard Deviation 132.81
|
|
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
Percent Change to Week 104; n=85, n=45
|
54.39 percent change in CTX
Standard Deviation 111.97
|
72.84 percent change in CTX
Standard Deviation 100.91
|
SECONDARY outcome
Timeframe: Baseline through 104 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. The n's are the number of participants with fractures.
Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
New Fractures at 104 Weeks (n=5, n=6)
|
7 number of fractures
|
7 number of fractures
|
|
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
Worsening Fractures at 104 Weeks (n=2, n=2)
|
3 number of fractures
|
3 number of fractures
|
SECONDARY outcome
Timeframe: Baseline Through 104 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Non-Vertebra Fracture - Fragility - 104 Weeks
|
1 number of fractures
|
1 number of fractures
|
|
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Non-Vertebra Fracture - Traumatic - 104 Weeks
|
3 number of fractures
|
4 number of fractures
|
|
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Vertebral Fracture - Traumatic - 104 Weeks
|
0 number of fractures
|
0 number of fractures
|
|
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Vertebral Fracture - Fragility - 104 Weeks
|
0 number of fractures
|
1 number of fractures
|
SECONDARY outcome
Timeframe: Baseline, 76 Weeks, 104 WeeksPopulation: Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement.
Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).
Outcome measures
| Measure |
Teriparatide
n=136 Participants
20 micrograms for 104 weeks
|
Placebo
n=67 Participants
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|
|
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Week 76: 1- None
|
78 participants
|
38 participants
|
|
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Week 76: 2- Mild
|
31 participants
|
13 participants
|
|
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Week 76: 3- Moderate
|
4 participants
|
4 participants
|
|
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Week 76: 4- Severe
|
0 participants
|
0 participants
|
|
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Week 104: 1- None
|
66 participants
|
32 participants
|
|
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Week 104: 2- Mild
|
23 participants
|
13 participants
|
|
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Week 104: 3- Moderate
|
3 participants
|
2 participants
|
|
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Week 104: 4- Severe
|
0 participants
|
0 participants
|
Adverse Events
Teriparatide (During 52 Weeks)
Serious events: 7 serious events
Other events: 115 other events
Deaths: 0 deaths
Placebo (During 52 Weeks)
Serious events: 7 serious events
Other events: 59 other events
Deaths: 0 deaths
Teriparatide (During 76 Weeks)
Serious events: 10 serious events
Other events: 123 other events
Deaths: 0 deaths
Placebo (During 76 Weeks)
Serious events: 9 serious events
Other events: 60 other events
Deaths: 0 deaths
Teriparatide (During 104 Weeks)
Serious events: 12 serious events
Other events: 125 other events
Deaths: 0 deaths
Placebo (During 104 Weeks)
Serious events: 13 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide (During 52 Weeks)
n=136 participants at risk
20 micrograms for 104 weeks
|
Placebo (During 52 Weeks)
n=67 participants at risk
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
Teriparatide (During 76 Weeks)
n=136 participants at risk
20 micrograms for 104 weeks
|
Placebo (During 76 Weeks)
n=67 participants at risk
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
Teriparatide (During 104 Weeks)
n=136 participants at risk
20 micrograms for 104 weeks
|
Placebo (During 104 Weeks)
n=67 participants at risk
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Eye disorders
Cataract
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Colonic polyp
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
2/136 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Infections and infestations
Cellulitis
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Injury, poisoning and procedural complications
Brachial plexus injury
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Investigations
Blood pressure decreased
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Vascular disorders
Artery dissection
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
Other adverse events
| Measure |
Teriparatide (During 52 Weeks)
n=136 participants at risk
20 micrograms for 104 weeks
|
Placebo (During 52 Weeks)
n=67 participants at risk
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
Teriparatide (During 76 Weeks)
n=136 participants at risk
20 micrograms for 104 weeks
|
Placebo (During 76 Weeks)
n=67 participants at risk
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
Teriparatide (During 104 Weeks)
n=136 participants at risk
20 micrograms for 104 weeks
|
Placebo (During 104 Weeks)
n=67 participants at risk
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.4%
10/136 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
8.1%
11/136 • Number of events 13 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
8.8%
12/136 • Number of events 14 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
6/136 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.9%
8/136 • Number of events 15 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
9.0%
6/67 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
3/136 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.4%
6/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Gastrointestinal disorders
Stomatitis
|
1.5%
2/136 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.4%
6/136 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
General disorders
Injection site reaction
|
3.7%
5/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
11.9%
8/67 • Number of events 14 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.7%
5/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
11.9%
8/67 • Number of events 14 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.7%
5/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
11.9%
8/67 • Number of events 14 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Immune system disorders
Seasonal allergy
|
5.9%
8/136 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.9%
8/136 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
8.8%
12/136 • Number of events 15 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
9.0%
6/67 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Infections and infestations
Cystitis
|
5.1%
7/136 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 10 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.9%
8/136 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
27.9%
38/136 • Number of events 66 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
40.3%
27/67 • Number of events 37 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
33.1%
45/136 • Number of events 89 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
43.3%
29/67 • Number of events 51 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
40.4%
55/136 • Number of events 113 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
47.8%
32/67 • Number of events 68 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
8/136 • Number of events 10 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
8.1%
11/136 • Number of events 13 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
10.3%
14/136 • Number of events 16 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
11.9%
8/67 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
6.6%
9/136 • Number of events 9 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
9.0%
6/67 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
8.1%
11/136 • Number of events 12 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
10.4%
7/67 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
10.3%
14/136 • Number of events 15 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
16.4%
11/67 • Number of events 12 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Investigations
Blood alkaline phosphatase increased
|
2.9%
4/136 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
2.9%
4/136 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.7%
5/136 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
8/136 • Number of events 9 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.9%
8/136 • Number of events 9 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
10.4%
7/67 • Number of events 9 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.4%
10/136 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
13.4%
9/67 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
17/136 • Number of events 18 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
13.4%
9/67 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
16.2%
22/136 • Number of events 24 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
22.4%
15/67 • Number of events 20 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
18.4%
25/136 • Number of events 33 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
23.9%
16/67 • Number of events 23 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
3/136 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.7%
5/136 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.9%
8/136 • Number of events 9 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.74%
1/136 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
2.2%
3/136 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
2.9%
4/136 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.6%
9/136 • Number of events 10 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.4%
10/136 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
10.3%
14/136 • Number of events 16 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
9.0%
6/67 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.2%
3/136 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.7%
5/136 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Nervous system disorders
Dizziness
|
5.9%
8/136 • Number of events 10 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
8.1%
11/136 • Number of events 14 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
8.8%
12/136 • Number of events 18 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Nervous system disorders
Headache
|
6.6%
9/136 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.4%
10/136 • Number of events 14 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.4%
10/136 • Number of events 15 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Psychiatric disorders
Insomnia
|
2.2%
3/136 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.0%
2/67 • Number of events 2 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.9%
8/136 • Number of events 9 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.9%
8/136 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 3 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.6%
9/136 • Number of events 16 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.4%
10/136 • Number of events 22 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.5%
3/67 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.7%
5/136 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.7%
5/136 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.4%
6/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
4.4%
6/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
7.5%
5/67 • Number of events 6 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/136 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.7%
5/136 • Number of events 8 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 10 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
|
Surgical and medical procedures
Tooth extraction
|
2.9%
4/136 • Number of events 5 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
0.00%
0/67 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
3.7%
5/136 • Number of events 7 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
1.5%
1/67 • Number of events 1 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
5.1%
7/136 • Number of events 11 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
6.0%
4/67 • Number of events 4 • Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60