Trial Outcomes & Findings for A Study of LY2541546 in Women With Low Bone Mineral Density (NCT NCT01144377)
NCT ID: NCT01144377
Last Updated: 2019-09-17
Results Overview
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Baseline, 52 weeks
Results posted on
2019-09-17
Participant Flow
After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
Participant milestones
| Measure |
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
|
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
|
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
|
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
|
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period (for an additional 40 weeks for a total of 52 weeks follow-up for the main study participants only).
|
|---|---|---|---|---|---|
|
52 Week Treatment Period
STARTED
|
31
|
30
|
30
|
26
|
37
|
|
52 Week Treatment Period
Received at Least One Dose of Study Drug
|
31
|
30
|
30
|
25
|
37
|
|
52 Week Treatment Period
COMPLETED
|
26
|
29
|
25
|
22
|
34
|
|
52 Week Treatment Period
NOT COMPLETED
|
5
|
1
|
5
|
4
|
3
|
|
12 Week Safety Follow-up Period
STARTED
|
26
|
29
|
25
|
22
|
34
|
|
12 Week Safety Follow-up Period
COMPLETED
|
26
|
29
|
25
|
22
|
34
|
|
12 Week Safety Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Optional 40 Week Safety Follow-up Period
STARTED
|
22
|
25
|
23
|
3
|
23
|
|
Optional 40 Week Safety Follow-up Period
COMPLETED
|
21
|
24
|
23
|
3
|
21
|
|
Optional 40 Week Safety Follow-up Period
NOT COMPLETED
|
1
|
1
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
|
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
|
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
|
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
|
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period (for an additional 40 weeks for a total of 52 weeks follow-up for the main study participants only).
|
|---|---|---|---|---|---|
|
52 Week Treatment Period
Adverse Event
|
0
|
0
|
3
|
2
|
1
|
|
52 Week Treatment Period
Entry Criteria Not Met
|
0
|
0
|
1
|
1
|
0
|
|
52 Week Treatment Period
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
52 Week Treatment Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
52 Week Treatment Period
Withdrawal by Subject
|
4
|
1
|
1
|
1
|
0
|
|
52 Week Treatment Period
Sponsor Decision
|
0
|
0
|
0
|
0
|
1
|
|
Optional 40 Week Safety Follow-up Period
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
|
Optional 40 Week Safety Follow-up Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Optional 40 Week Safety Follow-up Period
Sponsor Decision
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2541546 in Women With Low Bone Mineral Density
Baseline characteristics by cohort
| Measure |
180 mg LY2541546 Q4W + Placebo
n=31 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=30 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=30 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=25 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=37 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.78 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
64.17 years
STANDARD_DEVIATION 8.20 • n=7 Participants
|
66.12 years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
63.56 years
STANDARD_DEVIATION 8.02 • n=4 Participants
|
65.17 years
STANDARD_DEVIATION 8.91 • n=21 Participants
|
65.22 years
STANDARD_DEVIATION 8.38 • n=8 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
153 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
115 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
87 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
|
Region of Enrollment
Estonia
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Region of Enrollment
Lithuania
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
|
Lumbar Spine Bone Mineral Density (Baseline)
|
0.78 grams/square centimeter (g/cm^2)
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.78 grams/square centimeter (g/cm^2)
STANDARD_DEVIATION 0.07 • n=7 Participants
|
0.80 grams/square centimeter (g/cm^2)
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.77 grams/square centimeter (g/cm^2)
STANDARD_DEVIATION 0.09 • n=4 Participants
|
0.78 grams/square centimeter (g/cm^2)
STANDARD_DEVIATION 0.09 • n=21 Participants
|
0.78 grams/square centimeter (g/cm^2)
STANDARD_DEVIATION 0.09 • n=8 Participants
|
|
Femoral Neck Bone Mineral Density (Baseline)
|
0.66 g/cm^2
STANDARD_DEVIATION 0.15 • n=5 Participants
|
0.66 g/cm^2
STANDARD_DEVIATION 0.15 • n=7 Participants
|
0.69 g/cm^2
STANDARD_DEVIATION 0.11 • n=5 Participants
|
0.63 g/cm^2
STANDARD_DEVIATION 0.11 • n=4 Participants
|
0.66 g/cm^2
STANDARD_DEVIATION 0.17 • n=21 Participants
|
0.66 g/cm^2
STANDARD_DEVIATION 0.14 • n=8 Participants
|
|
Total Hip Bone Mineral Density (Baseline)
|
0.75 grams/square centimeter
STANDARD_DEVIATION 0.11 • n=5 Participants
|
0.75 grams/square centimeter
STANDARD_DEVIATION 0.13 • n=7 Participants
|
0.77 grams/square centimeter
STANDARD_DEVIATION 0.10 • n=5 Participants
|
0.73 grams/square centimeter
STANDARD_DEVIATION 0.11 • n=4 Participants
|
0.73 grams/square centimeter
STANDARD_DEVIATION 0.14 • n=21 Participants
|
0.75 grams/square centimeter
STANDARD_DEVIATION 0.12 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, 52 weeksPopulation: Participants who received at least one dose of study drug with baseline and at least one post-baseline lumbar spine BMD value.
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
Outcome measures
| Measure |
180 mg LY2541546 Q4W + Placebo
n=27 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=29 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=26 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=22 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=34 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)
|
0.065 g/cm^2
Interval 0.048 to 0.082
|
0.115 g/cm^2
Interval 0.099 to 0.131
|
0.142 g/cm^2
Interval 0.125 to 0.158
|
0.054 g/cm^2
Interval 0.036 to 0.073
|
-0.011 g/cm^2
Interval -0.026 to 0.004
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks and 24 weeks and 64 weeksPopulation: Participants who received at least one dose of study drug with baseline and at least one post-baseline lumbar spine BMD value.
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate
Outcome measures
| Measure |
180 mg LY2541546 Q4W + Placebo
n=29 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=30 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=30 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=24 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=36 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
Week 12
|
0.028 g/cm^2
Interval 0.02 to 0.037
|
0.048 g/cm^2
Interval 0.039 to 0.057
|
0.057 g/cm^2
Interval 0.048 to 0.065
|
0.039 g/cm^2
Interval 0.029 to 0.049
|
-0.007 g/cm^2
Interval -0.015 to 0.001
|
|
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
Week 24
|
0.049 g/cm^2
Interval 0.037 to 0.061
|
0.083 g/cm^2
Interval 0.071 to 0.094
|
0.098 g/cm^2
Interval 0.086 to 0.109
|
0.048 g/cm^2
Interval 0.035 to 0.061
|
-0.006 g/cm^2
Interval -0.016 to 0.004
|
|
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
Week 64
|
0.046 g/cm^2
Interval 0.032 to 0.061
|
0.098 g/cm^2
Interval 0.083 to 0.112
|
0.135 g/cm^2
Interval 0.12 to 0.15
|
0.046 g/cm^2
Interval 0.029 to 0.062
|
-0.007 g/cm^2
Interval -0.02 to 0.006
|
SECONDARY outcome
Timeframe: Baseline, 24 weeks and 52 weeks and 64 weeksPopulation: Participants who received at least one dose of study drug with baseline and at least one post-baseline femoral neck or total hip BMD value.
Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate.
Outcome measures
| Measure |
180 mg LY2541546 Q4W + Placebo
n=27 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=29 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=28 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=23 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=36 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Femoral Neck BMD Week 24
|
0.010 g/cm^2
Interval 0.002 to 0.019
|
0.017 g/cm^2
Interval 0.009 to 0.025
|
0.026 g/cm^2
Interval 0.018 to 0.034
|
0.002 g/cm^2
Interval -0.007 to 0.011
|
0.002 g/cm^2
Interval -0.005 to 0.009
|
|
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Total Hip BMD Week 24
|
0.007 g/cm^2
Interval -0.001 to 0.014
|
0.020 g/cm^2
Interval 0.013 to 0.027
|
0.031 g/cm^2
Interval 0.024 to 0.039
|
0.015 g/cm^2
Interval 0.007 to 0.023
|
-0.007 g/cm^2
Interval -0.014 to -0.001
|
|
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Femoral Neck BMD Week 52
|
0.018 g/cm^2
Interval 0.01 to 0.026
|
0.025 g/cm^2
Interval 0.017 to 0.033
|
0.044 g/cm^2
Interval 0.035 to 0.052
|
0.014 g/cm^2
Interval 0.005 to 0.024
|
0.003 g/cm^2
Interval -0.005 to 0.01
|
|
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Total Hip BMD Week 52
|
0.017 g/cm^2
Interval 0.008 to 0.025
|
0.032 g/cm^2
Interval 0.023 to 0.04
|
0.051 g/cm^2
Interval 0.043 to 0.06
|
0.019 g/cm^2
Interval 0.009 to 0.029
|
-0.004 g/cm^2
Interval -0.012 to 0.003
|
|
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Femoral Neck BMD Week 64
|
0.016 g/cm^2
Interval 0.007 to 0.026
|
0.028 g/cm^2
Interval 0.019 to 0.037
|
0.038 g/cm^2
Interval 0.029 to 0.048
|
0.013 g/cm^2
Interval 0.002 to 0.023
|
0.002 g/cm^2
Interval -0.007 to 0.01
|
|
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Total Hip BMD Week 64
|
0.011 g/cm^2
Interval 0.001 to 0.02
|
0.031 g/cm^2
Interval 0.022 to 0.04
|
0.047 g/cm^2
Interval 0.038 to 0.056
|
0.021 g/cm^2
Interval 0.011 to 0.03
|
-0.007 g/cm^2
Interval -0.015 to 0.001
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Participants who received at least one dose of study drug with baseline and at least one post-baseline total radius of the wrist BMD value.
Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate.
Outcome measures
| Measure |
180 mg LY2541546 Q4W + Placebo
n=24 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=29 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=26 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=22 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=32 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)
|
-0.005 g/cm^2
Interval -0.011 to 0.001
|
-0.005 g/cm^2
Interval -0.01 to 0.001
|
-0.001 g/cm^2
Interval -0.007 to 0.005
|
-0.002 g/cm^2
Interval -0.009 to 0.004
|
-0.005 g/cm^2
Interval -0.01 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Participants who received at least one dose of study drug with baseline and at least one post-baseline bone-specific alkaline phosphatase value.
Outcome measures
| Measure |
180 mg LY2541546 Q4W + Placebo
n=27 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=29 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=26 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=22 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=33 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)
|
-6.000 units/liter
Interval -12.6 to 0.3
|
-2.000 units/liter
Interval -10.4 to 4.5
|
1.600 units/liter
Interval -4.4 to 9.8
|
-3.150 units/liter
Interval -10.0 to 2.9
|
-3.900 units/liter
Interval -11.4 to 4.3
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Participants who received at least one dose of study drug with baseline and at least one post-baseline serum type I collagen fragment value.
Outcome measures
| Measure |
180 mg LY2541546 Q4W + Placebo
n=26 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=29 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=25 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=21 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=32 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)
|
-0.014 nanograms/milliliter
Interval -0.116 to 0.079
|
-0.088 nanograms/milliliter
Interval -0.191 to 0.03
|
-0.038 nanograms/milliliter
Interval -0.199 to -0.009
|
-0.022 nanograms/milliliter
Interval -0.076 to 0.029
|
0.037 nanograms/milliliter
Interval -0.076 to 0.129
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Participants who received at least one dose of study drug with baseline and at least one post-baseline osteocalcin value.
Outcome measures
| Measure |
180 mg LY2541546 Q4W + Placebo
n=26 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=29 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=25 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=22 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=32 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Osteocalcin
|
-2.087 micrograms/liter
Interval -3.998 to 2.411
|
-0.764 micrograms/liter
Interval -7.762 to 3.704
|
0.823 micrograms/liter
Interval -3.704 to 5.116
|
-3.322 micrograms/liter
Interval -5.586 to 4.822
|
-2.029 micrograms/liter
Interval -6.88 to 2.587
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Participants who received at least one dose of study drug with baseline and at least one post-baseline serum N-terminal extension propeptide of type I collagen value.
Outcome measures
| Measure |
180 mg LY2541546 Q4W + Placebo
n=26 Participants
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=29 Participants
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=25 Participants
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=22 Participants
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=32 Participants
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)
|
-12.250 nanograms/milliliter
Interval -19.3 to 1.3
|
-4.200 nanograms/milliliter
Interval -27.2 to 6.7
|
-1.100 nanograms/milliliter
Interval -12.8 to 10.2
|
-16.050 nanograms/milliliter
Interval -21.7 to 0.1
|
-5.800 nanograms/milliliter
Interval -11.55 to 5.45
|
Adverse Events
180 mg LY2541546 Q4W + Placebo
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
180 mg LY2541546 Q2W
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
270 mg LY2541546 Q2W
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
270 mg LY2541546 Q12W + Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo Q2W
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
180 mg LY2541546 Q4W + Placebo
n=31 participants at risk
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=30 participants at risk
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=30 participants at risk
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=25 participants at risk
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=37 participants at risk
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/31
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
0.00%
0/37
|
|
Gastrointestinal disorders
Mechanical ileus
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
3.2%
1/31 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
0.00%
0/25
|
0.00%
0/37
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.00%
0/31
|
0.00%
0/30
|
3.3%
1/30 • Number of events 2
|
0.00%
0/25
|
0.00%
0/37
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
4.0%
1/25 • Number of events 1
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
Other adverse events
| Measure |
180 mg LY2541546 Q4W + Placebo
n=31 participants at risk
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
|
180 mg LY2541546 Q2W
n=30 participants at risk
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q2W
n=30 participants at risk
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
270 mg LY2541546 Q12W + Placebo
n=25 participants at risk
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
|
Placebo Q2W
n=37 participants at risk
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/31
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
13.5%
5/37 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.5%
2/31 • Number of events 2
|
13.3%
4/30 • Number of events 6
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
0.00%
0/25
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.7%
3/31 • Number of events 4
|
6.7%
2/30 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
8.0%
2/25 • Number of events 3
|
5.4%
2/37 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31
|
6.7%
2/30 • Number of events 3
|
3.3%
1/30 • Number of events 2
|
0.00%
0/25
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31
|
6.7%
2/30 • Number of events 3
|
6.7%
2/30 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
0.00%
0/37
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
10.0%
3/30 • Number of events 4
|
0.00%
0/25
|
8.1%
3/37 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Cardiac disorders
Ventricular extrasystoles
|
9.7%
3/31 • Number of events 5
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/37
|
|
Ear and labyrinth disorders
Vertigo
|
6.5%
2/31 • Number of events 6
|
0.00%
0/30
|
0.00%
0/30
|
8.0%
2/25 • Number of events 2
|
0.00%
0/37
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
0.00%
0/37
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
1/31 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
10.0%
3/30 • Number of events 3
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31
|
16.7%
5/30 • Number of events 5
|
10.0%
3/30 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
5.4%
2/37 • Number of events 4
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • Number of events 2
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
5.4%
2/37 • Number of events 4
|
|
Gastrointestinal disorders
Periodontal disease
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Fatigue
|
6.5%
2/31 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
10.8%
4/37 • Number of events 4
|
|
General disorders
Injection site bruising
|
3.2%
1/31 • Number of events 4
|
10.0%
3/30 • Number of events 9
|
6.7%
2/30 • Number of events 7
|
24.0%
6/25 • Number of events 11
|
8.1%
3/37 • Number of events 3
|
|
General disorders
Injection site erythema
|
9.7%
3/31 • Number of events 3
|
10.0%
3/30 • Number of events 5
|
6.7%
2/30 • Number of events 3
|
0.00%
0/25
|
0.00%
0/37
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
5.4%
2/37 • Number of events 3
|
|
General disorders
Injection site induration
|
6.5%
2/31 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
General disorders
Injection site pain
|
12.9%
4/31 • Number of events 7
|
16.7%
5/30 • Number of events 8
|
3.3%
1/30 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Injection site pruritus
|
6.5%
2/31 • Number of events 2
|
16.7%
5/30 • Number of events 7
|
13.3%
4/30 • Number of events 5
|
0.00%
0/25
|
0.00%
0/37
|
|
General disorders
Injection site reaction
|
0.00%
0/31
|
6.7%
2/30 • Number of events 6
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
General disorders
Injection site swelling
|
19.4%
6/31 • Number of events 11
|
10.0%
3/30 • Number of events 5
|
16.7%
5/30 • Number of events 15
|
8.0%
2/25 • Number of events 3
|
0.00%
0/37
|
|
General disorders
Oedema peripheral
|
6.5%
2/31 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic cyst
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Asymptomatic bacteriuria
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
10.0%
3/30 • Number of events 3
|
0.00%
0/25
|
0.00%
0/37
|
|
Infections and infestations
Bronchitis
|
9.7%
3/31 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
4.0%
1/25 • Number of events 2
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Cystitis
|
12.9%
4/31 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
5.4%
2/37 • Number of events 3
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/31
|
6.7%
2/30 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
0.00%
0/25
|
0.00%
0/37
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Herpes zoster
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Influenza
|
6.5%
2/31 • Number of events 2
|
0.00%
0/30
|
0.00%
0/30
|
4.0%
1/25 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
51.6%
16/31 • Number of events 20
|
26.7%
8/30 • Number of events 11
|
36.7%
11/30 • Number of events 19
|
28.0%
7/25 • Number of events 8
|
32.4%
12/37 • Number of events 16
|
|
Infections and infestations
Oral herpes
|
6.5%
2/31 • Number of events 2
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Infections and infestations
Periodontitis
|
0.00%
0/31
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
0.00%
0/25
|
8.1%
3/37 • Number of events 3
|
|
Infections and infestations
Pharyngitis
|
3.2%
1/31 • Number of events 1
|
10.0%
3/30 • Number of events 4
|
10.0%
3/30 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
8.1%
3/37 • Number of events 3
|
|
Infections and infestations
Respiratory tract infection viral
|
9.7%
3/31 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Infections and infestations
Rhinitis
|
0.00%
0/31
|
0.00%
0/30
|
13.3%
4/30 • Number of events 4
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
13.3%
4/30 • Number of events 4
|
8.0%
2/25 • Number of events 2
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
8.0%
2/25 • Number of events 2
|
2.7%
1/37 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
9.7%
3/31 • Number of events 3
|
3.3%
1/30 • Number of events 3
|
6.7%
2/30 • Number of events 2
|
0.00%
0/25
|
13.5%
5/37 • Number of events 6
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
6.5%
2/31 • Number of events 2
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/31
|
6.7%
2/30 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Investigations
Blood 1,25-dihydroxycholecalciferol increased
|
19.4%
6/31 • Number of events 6
|
13.3%
4/30 • Number of events 5
|
13.3%
4/30 • Number of events 4
|
8.0%
2/25 • Number of events 2
|
13.5%
5/37 • Number of events 5
|
|
Investigations
Hepatic enzyme increased
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
0.00%
0/25
|
0.00%
0/37
|
|
Investigations
Urine calcium decreased
|
6.5%
2/31 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
0.00%
0/37
|
|
Investigations
Urine phosphorus decreased
|
6.5%
2/31 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.2%
1/31 • Number of events 1
|
10.0%
3/30 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
2/31 • Number of events 3
|
10.0%
3/30 • Number of events 5
|
6.7%
2/30 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
13.5%
5/37 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.4%
6/31 • Number of events 6
|
10.0%
3/30 • Number of events 4
|
6.7%
2/30 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
10.8%
4/37 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/31
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
0.00%
0/25
|
5.4%
2/37 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
6.5%
2/31 • Number of events 2
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.5%
2/31 • Number of events 2
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/31
|
6.7%
2/30 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.5%
2/31 • Number of events 2
|
10.0%
3/30 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.5%
2/31 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • Number of events 4
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.2%
1/31 • Number of events 1
|
13.3%
4/30 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
5.4%
2/37 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • Number of events 2
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.2%
1/31 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
6.5%
2/31 • Number of events 2
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/25
|
0.00%
0/37
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/31
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
8.1%
3/37 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Number of events 2
|
10.0%
3/30 • Number of events 4
|
0.00%
0/30
|
0.00%
0/25
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.00%
0/31
|
3.3%
1/30 • Number of events 1
|
10.0%
3/30 • Number of events 6
|
0.00%
0/25
|
0.00%
0/37
|
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