Trial Outcomes & Findings for Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis (NCT NCT00343252)
NCT ID: NCT00343252
Last Updated: 2011-05-26
Results Overview
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
COMPLETED
PHASE3
712 participants
6 Months
2011-05-26
Participant Flow
712 participants were randomized: 361 to teriparatide; 351 to risedronate. 2 participants did not receive drug. Only randomized participants who received at least 1 dose of drug were analyzed. At 18 months, reason for discontinuation was corrected from sponsor decision to entry criteria not met (1) and protocol violation (1) for 2 participants.
Participant milestones
| Measure |
Teriparatide
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
All Randomized Participants
STARTED
|
361
|
351
|
|
All Randomized Participants
COMPLETED
|
259
|
269
|
|
All Randomized Participants
NOT COMPLETED
|
102
|
82
|
|
6 Months (All Treated Participants)
STARTED
|
360
|
350
|
|
6 Months (All Treated Participants)
COMPLETED
|
304
|
306
|
|
6 Months (All Treated Participants)
NOT COMPLETED
|
56
|
44
|
|
12 Months (All Treated Participants)
STARTED
|
360
|
350
|
|
12 Months (All Treated Participants)
COMPLETED
|
274
|
281
|
|
12 Months (All Treated Participants)
NOT COMPLETED
|
86
|
69
|
|
18 Months (All Treated Participants)
STARTED
|
360
|
350
|
|
18 Months (All Treated Participants)
COMPLETED
|
259
|
269
|
|
18 Months (All Treated Participants)
NOT COMPLETED
|
101
|
81
|
Reasons for withdrawal
| Measure |
Teriparatide
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
6 Months (All Treated Participants)
Adverse Event
|
17
|
11
|
|
6 Months (All Treated Participants)
Death
|
0
|
2
|
|
6 Months (All Treated Participants)
Entry Criteria Not Met
|
10
|
8
|
|
6 Months (All Treated Participants)
Lack of Efficacy
|
0
|
1
|
|
6 Months (All Treated Participants)
Lost to Follow-up
|
0
|
4
|
|
6 Months (All Treated Participants)
Physician Decision
|
1
|
3
|
|
6 Months (All Treated Participants)
Protocol Violation
|
2
|
2
|
|
6 Months (All Treated Participants)
Sponsor Decision
|
7
|
4
|
|
6 Months (All Treated Participants)
Withdrawal by Subject
|
19
|
9
|
|
12 Months (All Treated Participants)
Adverse Event
|
22
|
20
|
|
12 Months (All Treated Participants)
Death
|
3
|
3
|
|
12 Months (All Treated Participants)
Entry Criteria Not Met
|
10
|
10
|
|
12 Months (All Treated Participants)
Lack of Efficacy
|
1
|
1
|
|
12 Months (All Treated Participants)
Lost to Follow-up
|
1
|
5
|
|
12 Months (All Treated Participants)
Physician Decision
|
4
|
5
|
|
12 Months (All Treated Participants)
Protocol Violation
|
3
|
2
|
|
12 Months (All Treated Participants)
Sponsor Decision
|
9
|
6
|
|
12 Months (All Treated Participants)
Withdrawal by Subject
|
33
|
17
|
|
18 Months (All Treated Participants)
Adverse Event
|
31
|
23
|
|
18 Months (All Treated Participants)
Death
|
4
|
5
|
|
18 Months (All Treated Participants)
Entry Criteria Not Met
|
11
|
10
|
|
18 Months (All Treated Participants)
Lack of Efficacy
|
1
|
1
|
|
18 Months (All Treated Participants)
Lost to Follow-up
|
3
|
7
|
|
18 Months (All Treated Participants)
Physician Decision
|
4
|
7
|
|
18 Months (All Treated Participants)
Protocol Violation
|
3
|
3
|
|
18 Months (All Treated Participants)
Sponsor Decision
|
8
|
5
|
|
18 Months (All Treated Participants)
Withdrawal by Subject
|
36
|
20
|
Baseline Characteristics
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
Baseline characteristics by cohort
| Measure |
Teriparatide
n=360 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=350 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
Total
n=710 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70.54 years
STANDARD_DEVIATION 8.80 • n=93 Participants
|
71.55 years
STANDARD_DEVIATION 8.12 • n=4 Participants
|
71.04 years
STANDARD_DEVIATION 8.48 • n=27 Participants
|
|
Sex: Female, Male
Female
|
360 Participants
n=93 Participants
|
350 Participants
n=4 Participants
|
710 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
67 participants
n=93 Participants
|
61 participants
n=4 Participants
|
128 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African Descent
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
285 participants
n=93 Participants
|
286 participants
n=4 Participants
|
571 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native American
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
48 participants
n=4 Participants
|
98 participants
n=27 Participants
|
|
Region of Enrollment
Argentina
|
38 participants
n=93 Participants
|
42 participants
n=4 Participants
|
80 participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
30 participants
n=93 Participants
|
30 participants
n=4 Participants
|
60 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=93 Participants
|
6 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
30 participants
n=93 Participants
|
30 participants
n=4 Participants
|
60 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
54 participants
n=93 Participants
|
55 participants
n=4 Participants
|
109 participants
n=27 Participants
|
|
Region of Enrollment
France
|
13 participants
n=93 Participants
|
10 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
22 participants
n=93 Participants
|
20 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
23 participants
n=93 Participants
|
23 participants
n=4 Participants
|
46 participants
n=27 Participants
|
|
Region of Enrollment
Puerto Rico
|
12 participants
n=93 Participants
|
10 participants
n=4 Participants
|
22 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
32 participants
n=93 Participants
|
32 participants
n=4 Participants
|
64 participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
13 participants
n=93 Participants
|
10 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
36 participants
n=93 Participants
|
34 participants
n=4 Participants
|
70 participants
n=27 Participants
|
|
Number of Vertebral Fractures
Unknown or No Vertebral Fractures
|
37 participants
n=93 Participants
|
35 participants
n=4 Participants
|
72 participants
n=27 Participants
|
|
Number of Vertebral Fractures
1 Vertebral Fracture
|
126 participants
n=93 Participants
|
104 participants
n=4 Participants
|
230 participants
n=27 Participants
|
|
Number of Vertebral Fractures
>=2 Vertebral Fractures
|
197 participants
n=93 Participants
|
211 participants
n=4 Participants
|
408 participants
n=27 Participants
|
|
Prior Osteoporosis Drug Use
Yes
|
267 participants
n=93 Participants
|
258 participants
n=4 Participants
|
525 participants
n=27 Participants
|
|
Prior Osteoporosis Drug Use
No
|
93 participants
n=93 Participants
|
92 participants
n=4 Participants
|
185 participants
n=27 Participants
|
|
Severity of Vertebral Fracture
Zero or Mild Severity (Grade 0)
|
50 participants
n=93 Participants
|
46 participants
n=4 Participants
|
96 participants
n=27 Participants
|
|
Severity of Vertebral Fracture
Moderate Severity (Grade 2)
|
160 participants
n=93 Participants
|
166 participants
n=4 Participants
|
326 participants
n=27 Participants
|
|
Severity of Vertebral Fracture
Severe (Grade 3)
|
142 participants
n=93 Participants
|
131 participants
n=4 Participants
|
273 participants
n=27 Participants
|
|
Severity of Vertebral Fracture
Unknown or Not Reported
|
8 participants
n=93 Participants
|
7 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Spinal Deformity Index
0
|
29 units on a scale
n=93 Participants
|
28 units on a scale
n=4 Participants
|
57 units on a scale
n=27 Participants
|
|
Spinal Deformity Index
1
|
11 units on a scale
n=93 Participants
|
16 units on a scale
n=4 Participants
|
27 units on a scale
n=27 Participants
|
|
Spinal Deformity Index
2
|
76 units on a scale
n=93 Participants
|
67 units on a scale
n=4 Participants
|
143 units on a scale
n=27 Participants
|
|
Spinal Deformity Index
>=3
|
236 units on a scale
n=93 Participants
|
232 units on a scale
n=4 Participants
|
468 units on a scale
n=27 Participants
|
|
Spinal Deformity Index
Unknown or Not Reported
|
8 units on a scale
n=93 Participants
|
7 units on a scale
n=4 Participants
|
15 units on a scale
n=27 Participants
|
|
24-Hour Average Back Pain Score
|
5.34 units on a scale
STANDARD_DEVIATION 1.86 • n=93 Participants
|
5.40 units on a scale
STANDARD_DEVIATION 1.85 • n=4 Participants
|
5.37 units on a scale
STANDARD_DEVIATION 1.85 • n=27 Participants
|
|
24-Hour Worst Back Pain Score
|
6.80 units on a scale
STANDARD_DEVIATION 1.63 • n=93 Participants
|
6.91 units on a scale
STANDARD_DEVIATION 1.54 • n=4 Participants
|
6.85 units on a scale
STANDARD_DEVIATION 1.59 • n=27 Participants
|
|
Body Mass Index
|
26.30 kilograms/meters squared
STANDARD_DEVIATION 5.01 • n=93 Participants
|
26.36 kilograms/meters squared
STANDARD_DEVIATION 4.91 • n=4 Participants
|
26.33 kilograms/meters squared
STANDARD_DEVIATION 4.96 • n=27 Participants
|
|
Duration of Back Pain
|
550.33 days
STANDARD_DEVIATION 918.18 • n=93 Participants
|
550.88 days
STANDARD_DEVIATION 750.47 • n=4 Participants
|
550.58 days
STANDARD_DEVIATION 842.78 • n=27 Participants
|
|
Height
|
154.82 centimeters
STANDARD_DEVIATION 7.41 • n=93 Participants
|
153.62 centimeters
STANDARD_DEVIATION 7.86 • n=4 Participants
|
154.23 centimeters
STANDARD_DEVIATION 7.66 • n=27 Participants
|
|
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) Score
|
47.08 units on a scale
STANDARD_DEVIATION 14.61 • n=93 Participants
|
46.98 units on a scale
STANDARD_DEVIATION 14.39 • n=4 Participants
|
47.03 units on a scale
STANDARD_DEVIATION 14.49 • n=27 Participants
|
|
Roland-Morris Disability Questionnaire Score
|
11.88 units on a scale
STANDARD_DEVIATION 5.47 • n=93 Participants
|
12.12 units on a scale
STANDARD_DEVIATION 5.40 • n=4 Participants
|
12.00 units on a scale
STANDARD_DEVIATION 5.44 • n=27 Participants
|
|
Weight
|
63.02 kilograms
STANDARD_DEVIATION 12.70 • n=93 Participants
|
62.27 kilograms
STANDARD_DEVIATION 12.58 • n=4 Participants
|
62.65 kilograms
STANDARD_DEVIATION 12.63 • n=27 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Outcome measures
| Measure |
Teriparatide
n=348 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=336 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Responder to Treatment
|
206 participants
|
193 participants
|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Non-Responder to Treatment
|
142 participants
|
143 participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
Outcome measures
| Measure |
Teriparatide
n=348 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=336 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Responder to Treatment
|
233 participants
|
220 participants
|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Non-Responder to Treatment
|
115 participants
|
116 participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Outcome measures
| Measure |
Teriparatide
n=347 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=336 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
Responder to Treatment
|
221 participants
|
211 participants
|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
Non-Responder to Treatment
|
126 participants
|
125 participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
Outcome measures
| Measure |
Teriparatide
n=347 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=336 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
Responder to Treatment
|
246 participants
|
238 participants
|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
Non-Responder to Treatment
|
101 participants
|
98 participants
|
SECONDARY outcome
Timeframe: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Outcome measures
| Measure |
Teriparatide
n=348 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=336 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 0
|
0 participants
|
0 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 30
|
26 participants
|
22 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 60
|
70 participants
|
74 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 90
|
110 participants
|
111 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 120
|
151 participants
|
145 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 150
|
175 participants
|
164 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 180
|
195 participants
|
181 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 210
|
206 participants
|
192 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 240
|
206 participants
|
193 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 270
|
206 participants
|
193 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Day 300
|
206 participants
|
193 participants
|
SECONDARY outcome
Timeframe: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Outcome measures
| Measure |
Teriparatide
n=348 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=336 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 180
|
195 participants
|
181 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 240
|
206 participants
|
193 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 300
|
224 participants
|
206 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 480
|
233 participants
|
220 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 540
|
233 participants
|
220 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 600
|
233 participants
|
220 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 0
|
0 participants
|
0 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 60
|
70 participants
|
74 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 120
|
151 participants
|
145 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 360
|
226 participants
|
209 participants
|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Day 420
|
233 participants
|
220 participants
|
SECONDARY outcome
Timeframe: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days.
Time to first occurrence of \>=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Outcome measures
| Measure |
Teriparatide
n=347 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=336 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 0
|
0 participants
|
0 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 30
|
40 participants
|
33 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 150
|
199 participants
|
178 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 180
|
212 participants
|
200 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 210
|
221 participants
|
210 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 240
|
221 participants
|
211 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 270
|
221 participants
|
211 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 300
|
221 participants
|
211 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 60
|
91 participants
|
86 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 90
|
136 participants
|
130 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Day 120
|
175 participants
|
162 participants
|
SECONDARY outcome
Timeframe: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600Population: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
Time to first occurrence of \>= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Outcome measures
| Measure |
Teriparatide
n=347 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=336 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 0
|
0 participants
|
0 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 60
|
91 participants
|
86 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 120
|
175 participants
|
162 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 180
|
212 participants
|
200 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 240
|
221 participants
|
211 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 300
|
234 participants
|
220 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 360
|
238 participants
|
226 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 420
|
246 participants
|
238 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 480
|
246 participants
|
238 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 540
|
246 participants
|
238 participants
|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Day 600
|
246 participants
|
238 participants
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Outcome measures
| Measure |
Teriparatide
n=334 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=311 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
|
-1.42 units on a scale
Standard Error 0.45
|
-1.41 units on a scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Outcome measures
| Measure |
Teriparatide
n=341 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=319 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
|
-1.58 units on a scale
Standard Error 0.48
|
-1.77 units on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Outcome measures
| Measure |
Teriparatide
n=343 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=322 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
|
-2.09 units on a scale
Standard Error 0.54
|
-2.12 units on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Outcome measures
| Measure |
Teriparatide
n=344 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=326 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
|
-2.80 units on a scale
Standard Error 1.11
|
-2.63 units on a scale
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Outcome measures
| Measure |
Teriparatide
n=344 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=327 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
|
-5.74 units on a scale
Standard Error 1.23
|
-5.27 units on a scale
Standard Error 1.22
|
SECONDARY outcome
Timeframe: Baseline through 12 MonthsPopulation: Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.
Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Teriparatide
n=360 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=350 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants With Adverse Events (Safety) During 12 Months
Serious Adverse Events
|
39 participants
|
50 participants
|
|
Number of Participants With Adverse Events (Safety) During 12 Months
Adverse Events
|
269 participants
|
266 participants
|
SECONDARY outcome
Timeframe: Baseline through 18 MonthsPopulation: Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.
Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Teriparatide
n=360 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=350 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants With Adverse Events (Safety) During 18 Months
Serious Adverse Events
|
55 participants
|
66 participants
|
|
Number of Participants With Adverse Events (Safety) During 18 Months
Adverse Events
|
277 participants
|
273 participants
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug.
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
Outcome measures
| Measure |
Teriparatide
n=360 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=349 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
Responder
|
248 participants
|
234 participants
|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
Non-Responder
|
112 participants
|
115 participants
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug.
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
Outcome measures
| Measure |
Teriparatide
n=360 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=349 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
Responder
|
260 participants
|
242 participants
|
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
Non-responder
|
100 participants
|
107 participants
|
SECONDARY outcome
Timeframe: Baseline through 18 MonthsPopulation: Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.
Time to first occurrence of \>= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Outcome measures
| Measure |
Teriparatide
n=360 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=349 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
|
248 participants
|
234 participants
|
SECONDARY outcome
Timeframe: Baseline through 18 MonthsPopulation: Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.
Time to first occurrence of \>=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Outcome measures
| Measure |
Teriparatide
n=360 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=349 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
|
260 participants
|
242 participants
|
SECONDARY outcome
Timeframe: Baseline, 18 MonthsPopulation: Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.
Outcome measures
| Measure |
Teriparatide
n=343 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=323 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
|
-3.21 units on a scale
Standard Error 0.54
|
-3.19 units on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline, 18 MonthsPopulation: Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Outcome measures
| Measure |
Teriparatide
n=344 Participants
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=327 Participants
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
|
-5.67 units on a scale
Standard Error 1.27
|
-5.17 units on a scale
Standard Error 1.26
|
Adverse Events
Teriparatide
Risedronate
Serious adverse events
| Measure |
Teriparatide
n=360 participants at risk
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=350 participants at risk
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.56%
2/360 • Number of events 2 • Baseline to 18 Months
|
0.86%
3/350 • Number of events 3 • Baseline to 18 Months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/360 • Baseline to 18 Months
|
0.86%
3/350 • Number of events 4 • Baseline to 18 Months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Cardiac disorders
Ventricular failure
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Eye disorders
Glaucoma
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Eye disorders
Oscillopsia
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/360 • Baseline to 18 Months
|
0.86%
3/350 • Number of events 3 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Crohn's disease
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.28%
1/360 • Number of events 2 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.83%
3/360 • Number of events 3 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
General disorders
Chest pain
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.86%
3/350 • Number of events 3 • Baseline to 18 Months
|
|
General disorders
Death
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
General disorders
Oedema peripheral
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
General disorders
Sudden death
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.83%
3/360 • Number of events 3 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Abscess limb
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Blister infected
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Infections and infestations
Cellulitis
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/360 • Baseline to 18 Months
|
1.1%
4/350 • Number of events 4 • Baseline to 18 Months
|
|
Infections and infestations
Helicobacter gastritis
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Herpes zoster disseminated
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Infection
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Osteomyelitis acute
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Pneumonia
|
0.56%
2/360 • Number of events 2 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 2 • Baseline to 18 Months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Respiratory tract infection
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Sepsis
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Septic shock
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Staphylococcal infection
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Urosepsis
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Infections and infestations
Vaginal abscess
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Infections and infestations
Wound infection
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.56%
2/360 • Number of events 2 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 3 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
5/360 • Number of events 5 • Baseline to 18 Months
|
3.1%
11/350 • Number of events 11 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 3 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
4/360 • Number of events 4 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.83%
3/360 • Number of events 4 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.28%
1/360 • Number of events 2 • Baseline to 18 Months
|
0.86%
3/350 • Number of events 3 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.86%
3/350 • Number of events 3 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 3 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.56%
2/360 • Number of events 2 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
2/360 • Number of events 3 • Baseline to 18 Months
|
0.86%
3/350 • Number of events 3 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome transformation
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
1.7%
6/350 • Number of events 7 • Baseline to 18 Months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Nervous system disorders
Hyperreflexia
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Nervous system disorders
Ischaemic stroke
|
0.56%
2/360 • Number of events 2 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Nervous system disorders
Myoclonus
|
0.56%
2/360 • Number of events 2 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Nervous system disorders
Nystagmus
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Nervous system disorders
Sciatica
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Nervous system disorders
Tremor
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Psychiatric disorders
Agitation
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Psychiatric disorders
Depression
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Psychiatric disorders
Suicide attempt
|
0.56%
2/360 • Number of events 2 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Renal and urinary disorders
Oliguria
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.86%
3/350 • Number of events 3 • Baseline to 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Social circumstances
Activities of daily living impaired
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Surgical and medical procedures
Vertebroplasty
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Vascular disorders
Hypertension
|
0.56%
2/360 • Number of events 2 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Vascular disorders
Hypertensive crisis
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Vascular disorders
Hypotension
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
|
Vascular disorders
Raynaud's phenomenon
|
0.28%
1/360 • Number of events 1 • Baseline to 18 Months
|
0.00%
0/350 • Baseline to 18 Months
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/360 • Baseline to 18 Months
|
0.57%
2/350 • Number of events 2 • Baseline to 18 Months
|
|
Vascular disorders
Vasospasm
|
0.00%
0/360 • Baseline to 18 Months
|
0.29%
1/350 • Number of events 1 • Baseline to 18 Months
|
Other adverse events
| Measure |
Teriparatide
n=360 participants at risk
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
|
Risedronate
n=350 participants at risk
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
16/360 • Number of events 19 • Baseline to 18 Months
|
6.3%
22/350 • Number of events 28 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Nausea
|
8.1%
29/360 • Number of events 37 • Baseline to 18 Months
|
8.6%
30/350 • Number of events 38 • Baseline to 18 Months
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
9/360 • Number of events 10 • Baseline to 18 Months
|
5.4%
19/350 • Number of events 22 • Baseline to 18 Months
|
|
Infections and infestations
Bronchitis
|
6.1%
22/360 • Number of events 29 • Baseline to 18 Months
|
7.1%
25/350 • Number of events 27 • Baseline to 18 Months
|
|
Infections and infestations
Influenza
|
8.1%
29/360 • Number of events 34 • Baseline to 18 Months
|
8.6%
30/350 • Number of events 37 • Baseline to 18 Months
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
30/360 • Number of events 35 • Baseline to 18 Months
|
7.1%
25/350 • Number of events 32 • Baseline to 18 Months
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
18/360 • Number of events 25 • Baseline to 18 Months
|
4.0%
14/350 • Number of events 17 • Baseline to 18 Months
|
|
Infections and infestations
Urinary tract infection
|
6.4%
23/360 • Number of events 29 • Baseline to 18 Months
|
5.1%
18/350 • Number of events 20 • Baseline to 18 Months
|
|
Injury, poisoning and procedural complications
Fall
|
9.2%
33/360 • Number of events 33 • Baseline to 18 Months
|
7.4%
26/350 • Number of events 35 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
36/360 • Number of events 51 • Baseline to 18 Months
|
12.0%
42/350 • Number of events 51 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
18/360 • Number of events 19 • Baseline to 18 Months
|
6.0%
21/350 • Number of events 22 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.9%
32/360 • Number of events 36 • Baseline to 18 Months
|
4.3%
15/350 • Number of events 19 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
20/360 • Number of events 21 • Baseline to 18 Months
|
4.3%
15/350 • Number of events 18 • Baseline to 18 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
25/360 • Number of events 34 • Baseline to 18 Months
|
7.7%
27/350 • Number of events 32 • Baseline to 18 Months
|
|
Nervous system disorders
Dizziness
|
5.8%
21/360 • Number of events 23 • Baseline to 18 Months
|
5.4%
19/350 • Number of events 21 • Baseline to 18 Months
|
|
Nervous system disorders
Headache
|
9.4%
34/360 • Number of events 44 • Baseline to 18 Months
|
6.9%
24/350 • Number of events 25 • Baseline to 18 Months
|
|
Vascular disorders
Hypertension
|
6.1%
22/360 • Number of events 22 • Baseline to 18 Months
|
6.0%
21/350 • Number of events 21 • Baseline to 18 Months
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60