Trial Outcomes & Findings for Effect of Teriparatide on Hip Fracture Healing (NCT NCT01473589)
NCT ID: NCT01473589
Last Updated: 2015-04-16
Results Overview
Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
122 participants
Primary outcome timeframe
12 months
Results posted on
2015-04-16
Participant Flow
Participant milestones
| Measure |
Teriparatide
Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
62
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
60
|
61
|
|
Overall Study
Completed 6 Months
|
51
|
54
|
|
Overall Study
Completed 12 Months
|
49
|
48
|
|
Overall Study
COMPLETED
|
49
|
46
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
| Measure |
Teriparatide
Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
11
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Entry criteria not met
|
0
|
1
|
Baseline Characteristics
Effect of Teriparatide on Hip Fracture Healing
Baseline characteristics by cohort
| Measure |
Teriparatide
n=60 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=61 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.49 years
STANDARD_DEVIATION 11.321 • n=5 Participants
|
70.96 years
STANDARD_DEVIATION 12.023 • n=7 Participants
|
69.73 years
STANDARD_DEVIATION 11.698 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
India
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Surgical screw type
Cancellous Screws
|
54 participants
n=5 Participants
|
53 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Surgical screw type
Sliding Hip Screws
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants who were randomized and received at least 1 dose of study drug.
Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
Outcome measures
| Measure |
Teriparatide
n=60 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=61 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
|
87 percentage of participants
Interval 77.0 to 93.0
|
86 percentage of participants
Interval 76.0 to 92.0
|
SECONDARY outcome
Timeframe: Randomization up to 12 monthsPopulation: Participants who were randomized and received at least 1 dose of study drug.
The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing. Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) \* 100.
Outcome measures
| Measure |
Teriparatide
n=60 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=61 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants With Radiographic Evidence of Healing
|
78.3 percentage of participants
|
78.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who were randomized, received treatment, and had baseline and at least one nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.
The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of \<7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores \>2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) \* 100.
Outcome measures
| Measure |
Teriparatide
n=47 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=49 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants With Pain Control During Ambulation
|
91.5 percentage of participants
|
89.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours. LOCF values used.
The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of \<7 in the 24 hours preceding a visit and no worsening of NRS \>2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) \* 100.
Outcome measures
| Measure |
Teriparatide
n=50 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=51 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
|
88.0 percentage of participants
|
82.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who were randomized, received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement. LOCF values used.
The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of \<7 during weight bearing and no worsening of NRS \>2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) \* 100.
Outcome measures
| Measure |
Teriparatide
n=47 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=50 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
|
89.4 percentage of participants
|
88.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.
Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) \* 100.
Outcome measures
| Measure |
Teriparatide
n=48 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=50 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants With Functional Evidence of Healing
|
85.4 percentage of participants
|
74.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who were randomized and received at least 1 dose of study drug and had at least 1 nonmissing post-baseline measurement. LOCF values used.
Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) \* 100.
Outcome measures
| Measure |
Teriparatide
n=48 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=50 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants Able to Ambulate
|
97.9 percentage of participants
|
98 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.
Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) \* 100.
Outcome measures
| Measure |
Teriparatide
n=56 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=58 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants Who Regain Their Prefracture Ambulatory Status
|
73.2 percentage of participants
|
56.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Participants who were randomized and received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement.
The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of \<7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Outcome measures
| Measure |
Teriparatide
n=47 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=50 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
During ambulation (n = 45, 46)
|
0.2 units on a scale
Standard Error 0.37
|
0.2 units on a scale
Standard Error 0.36
|
|
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
During 24 hours preceding visit (n = 47, 50)
|
-0.3 units on a scale
Standard Error 0.45
|
-0.8 units on a scale
Standard Error 0.42
|
|
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
On weight bearing (n = 46, 49)
|
0.7 units on a scale
Standard Error 0.39
|
0.8 units on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline, up to 6 MonthsPopulation: Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement.
The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Outcome measures
| Measure |
Teriparatide
n=45 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=47 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months in Gait Speed
|
-0.672 m/s
Standard Error 2.128
|
1.524 m/s
Standard Error 2.018
|
SECONDARY outcome
Timeframe: Baseline to revision surgery (up to 14.14 Months)Population: Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 51; placebo = 51.
Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.
Outcome measures
| Measure |
Teriparatide
n=60 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=59 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Time to Revision Surgery
|
358.5 days
Interval 15.0 to 430.0
|
350 days
Interval 12.0 to 412.0
|
SECONDARY outcome
Timeframe: Baseline, up to 6 MonthsPopulation: Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.
SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Teriparatide
n=58 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=59 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
PCS Month 6 (n = 49, 49)
|
-3.73 units on a scale
Standard Error 1.2
|
-4.75 units on a scale
Standard Error 1.2
|
|
Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
MCS Month 6 (n = 49, 49)
|
-0.58 units on a scale
Standard Error 2.1
|
-0.49 units on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline, up to 6 MonthsPopulation: Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.
WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Teriparatide
n=58 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=59 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Physical Function Score - Month 6 (n=48, 51)
|
12.9 units on a scale
Standard Error 4.36
|
12.8 units on a scale
Standard Error 4.25
|
|
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Pain Score - Month 6 ( n = 51, 51)
|
8.2 units on a scale
Standard Error 3.76
|
10.3 units on a scale
Standard Error 3.68
|
|
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Stiffness Score - Month 6 (n = 51, 51)
|
13.1 units on a scale
Standard Error 3.78
|
11.8 units on a scale
Standard Error 3.75
|
SECONDARY outcome
Timeframe: Baseline, up to 6 MonthsPopulation: All randomized participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur, and had baseline and at least 1 nonmissing post-baseline measurement.
The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.
Outcome measures
| Measure |
Teriparatide
n=51 Participants
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=51 Participants
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
|
7.4 units on a scale
Standard Error 4.02
|
7.6 units on a scale
Standard Error 3.87
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Teriparatide
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo Follow-up
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Teriparatide Follow-up
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=61 participants at risk
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Teriparatide
n=60 participants at risk
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo Follow-up
n=53 participants at risk
Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Teriparatide Follow-up
n=49 participants at risk
Follow-up after teriparatide 20 µg once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|---|---|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Hepatobiliary disorders
Hepatitis toxic
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Liver abscess
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Pneumonia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Wound
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Syncope
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Psychiatric disorders
Confusional state
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
Other adverse events
| Measure |
Placebo
n=61 participants at risk
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Teriparatide
n=60 participants at risk
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo Follow-up
n=53 participants at risk
Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Teriparatide Follow-up
n=49 participants at risk
Follow-up after teriparatide 20 µg once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Tremor
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Vertebral artery stenosis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Psychiatric disorders
Behavioural and psychiatric symptoms of dementia
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Psychiatric disorders
Depression
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Psychiatric disorders
Disorientation
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Psychiatric disorders
Insomnia
|
3.3%
2/61 • Number of events 2 • Randomization to Study Completion
|
5.0%
3/60 • Number of events 3 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Renal and urinary disorders
Pollakiuria
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/44 • Randomization to Study Completion
|
0.00%
0/43 • Randomization to Study Completion
|
2.6%
1/39 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/39 • Randomization to Study Completion
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/17 • Randomization to Study Completion
|
5.9%
1/17 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/14 • Randomization to Study Completion
|
0.00%
0/10 • Randomization to Study Completion
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.3%
1/44 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/43 • Randomization to Study Completion
|
0.00%
0/39 • Randomization to Study Completion
|
0.00%
0/39 • Randomization to Study Completion
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scar
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Surgical and medical procedures
Cataract operation
|
1.6%
1/61 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Surgical and medical procedures
Cholecystectomy
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Surgical and medical procedures
Sebaceous cyst excision
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Vascular disorders
Hypertension
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Vascular disorders
Thrombosis
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Cardiac disorders
Palpitations
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Eye disorders
Cataract
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Eye disorders
Conjunctival haemorrhage
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Eye disorders
Conjunctivitis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Eye disorders
Glaucoma
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Eye disorders
Macular degeneration
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
5.0%
3/60 • Number of events 3 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Gingival swelling
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/61 • Randomization to Study Completion
|
3.3%
2/60 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Periodontal inflammation
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
General disorders
Asthenia
|
3.3%
2/61 • Number of events 2 • Randomization to Study Completion
|
3.3%
2/60 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
General disorders
Facial pain
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
General disorders
Gait disturbance
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
General disorders
Oedema peripheral
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
General disorders
Pain
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
General disorders
Pyrexia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
General disorders
Sense of oppression
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
General disorders
Thirst
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Infections and infestations
Bronchitis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
4.1%
2/49 • Number of events 2 • Randomization to Study Completion
|
|
Infections and infestations
Cellulitis
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Cervicitis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Infections and infestations
Ear infection
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Eye infection
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Infections and infestations
Nail infection
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
3/61 • Number of events 4 • Randomization to Study Completion
|
6.7%
4/60 • Number of events 5 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Oral herpes
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Parotitis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Rhinitis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Skin infection
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Infections and infestations
Tinea pedis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Urinary tract infection
|
3.3%
2/61 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Infections and infestations
Wound infection
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 4 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Investigations
Blood pressure increased
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Investigations
Weight decreased
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Metabolism and nutrition disorders
Folate deficiency
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
3/61 • Number of events 3 • Randomization to Study Completion
|
5.0%
3/60 • Number of events 3 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
6.1%
3/49 • Number of events 3 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
6/61 • Number of events 6 • Randomization to Study Completion
|
5.0%
3/60 • Number of events 3 • Randomization to Study Completion
|
3.8%
2/53 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
3.3%
2/60 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.6%
4/61 • Number of events 4 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
4.1%
2/49 • Number of events 2 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
5.0%
3/60 • Number of events 3 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Nervous system disorders
Carotid arteriosclerosis
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/61 • Randomization to Study Completion
|
0.00%
0/60 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Nervous system disorders
Dizziness
|
4.9%
3/61 • Number of events 3 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Nervous system disorders
Headache
|
1.6%
1/61 • Number of events 1 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
1.9%
1/53 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/61 • Randomization to Study Completion
|
3.3%
2/60 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Presyncope
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
2.0%
1/49 • Number of events 1 • Randomization to Study Completion
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/61 • Randomization to Study Completion
|
1.7%
1/60 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/53 • Randomization to Study Completion
|
0.00%
0/49 • Randomization to Study Completion
|
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