Trial Outcomes & Findings for A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture (NCT NCT00887354)
NCT ID: NCT00887354
Last Updated: 2019-09-25
Results Overview
Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
224 participants
Primary outcome timeframe
Baseline, Week 78
Results posted on
2019-09-25
Participant Flow
Full Analysis Set (FAS) is defined as all randomized participants receiving at least one dose of study drug with at least one post-baseline efficacy measure.
Participant milestones
| Measure |
Teriparatide
20 microgram (mcg) a day by subcutaneous (SC) injection throughout study.
Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Treatment Phase (Week 0 to Week 26)
STARTED
|
111
|
113
|
|
Treatment Phase (Week 0 to Week 26)
Received at Least 1 Dose of Study Drug
|
106
|
110
|
|
Treatment Phase (Week 0 to Week 26)
Included in Full Analysis Set
|
86
|
85
|
|
Treatment Phase (Week 0 to Week 26)
COMPLETED
|
60
|
65
|
|
Treatment Phase (Week 0 to Week 26)
NOT COMPLETED
|
51
|
48
|
|
Open Label Phase (Week 26 to Week 78)
STARTED
|
60
|
65
|
|
Open Label Phase (Week 26 to Week 78)
COMPLETED
|
57
|
59
|
|
Open Label Phase (Week 26 to Week 78)
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Teriparatide
20 microgram (mcg) a day by subcutaneous (SC) injection throughout study.
Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Treatment Phase (Week 0 to Week 26)
Death
|
0
|
1
|
|
Treatment Phase (Week 0 to Week 26)
Sponsor Decision
|
1
|
1
|
|
Treatment Phase (Week 0 to Week 26)
Physician Decision
|
2
|
1
|
|
Treatment Phase (Week 0 to Week 26)
Withdrawal by Subject
|
14
|
8
|
|
Treatment Phase (Week 0 to Week 26)
Adverse Event
|
3
|
3
|
|
Treatment Phase (Week 0 to Week 26)
Lost to Follow-up
|
2
|
1
|
|
Treatment Phase (Week 0 to Week 26)
Entry Criteria Not Met
|
3
|
3
|
|
Treatment Phase (Week 0 to Week 26)
Caregiver Decision
|
1
|
2
|
|
Treatment Phase (Week 0 to Week 26)
No efficacy data
|
20
|
25
|
|
Treatment Phase (Week 0 to Week 26)
Not Treated
|
5
|
3
|
|
Open Label Phase (Week 26 to Week 78)
Death
|
0
|
2
|
|
Open Label Phase (Week 26 to Week 78)
Physician Decision
|
0
|
1
|
|
Open Label Phase (Week 26 to Week 78)
Withdrawal by Subject
|
1
|
2
|
|
Open Label Phase (Week 26 to Week 78)
Adverse Event
|
1
|
0
|
|
Open Label Phase (Week 26 to Week 78)
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
Baseline characteristics by cohort
| Measure |
Teriparatide
n=86 Participants
20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=85 Participants
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.2 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
76.4 years
STANDARD_DEVIATION 7.47 • n=7 Participants
|
76.8 years
STANDARD_DEVIATION 7.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 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
Greece
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
France
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 78Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
Outcome measures
| Measure |
Teriparatide
n=61 Participants
20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=66 Participants
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Change in Lumbar Spine Areal Bone Mineral Density (BMD)
|
0.094 gram per square centimeter (g/cm^2)
Standard Error 0.0075
|
0.055 gram per square centimeter (g/cm^2)
Standard Error 0.0081
|
SECONDARY outcome
Timeframe: Baseline, Week 26; Baseline, Week 52Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
Outcome measures
| Measure |
Teriparatide
n=61 Participants
20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=66 Participants
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Change in Lumbar Spine Areal Bone Mineral Density
Week 52
|
0.078 g/cm^2
Standard Error 0.0074
|
0.044 g/cm^2
Standard Error 0.0081
|
|
Change in Lumbar Spine Areal Bone Mineral Density
Week 26
|
0.053 g/cm^2
Standard Error 0.0074
|
0.032 g/cm^2
Standard Error 0.0081
|
SECONDARY outcome
Timeframe: Baseline, Week 26; Baseline, Week 52; Baseline, Week 78Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) . Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use.
Outcome measures
| Measure |
Teriparatide
n=60 Participants
20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=61 Participants
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
Total Hip 26 Weeks
|
-0.001 g/cm^2
Standard Error 0.0042
|
-0.001 g/cm^2
Standard Error 0.0042
|
|
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
Total Hip 52 Weeks
|
0.001 g/cm^2
Standard Error 0.0042
|
-0.001 g/cm^2
Standard Error 0.0042
|
|
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
Total Hip 78 Weeks
|
0.007 g/cm^2
Standard Error 0.0042
|
0.005 g/cm^2
Standard Error 0.0043
|
|
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
Femoral Neck 26 Weeks
|
0.002 g/cm^2
Standard Error 0.0044
|
-0.009 g/cm^2
Standard Error 0.0043
|
|
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
Femoral Neck 52 Weeks
|
-0.000 g/cm^2
Standard Error 0.0044
|
-0.006 g/cm^2
Standard Error 0.0044
|
|
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
Femoral Neck 78 Weeks
|
0.012 g/cm^2
Standard Error 0.0044
|
-0.007 g/cm^2
Standard Error 0.0045
|
SECONDARY outcome
Timeframe: Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26Population: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).
Outcome measures
| Measure |
Teriparatide
n=67 Participants
20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=65 Participants
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire
Week 18
|
14.37 units on a scale
Standard Error 1.256
|
12.81 units on a scale
Standard Error 1.260
|
|
Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire
Week 26
|
16.34 units on a scale
Standard Error 1.278
|
14.36 units on a scale
Standard Error 1.258
|
|
Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire
Week 6
|
7.37 units on a scale
Standard Error 1.065
|
5.10 units on a scale
Standard Error 1.087
|
|
Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire
Week 12
|
11.32 units on a scale
Standard Error 1.207
|
11.09 units on a scale
Standard Error 1.208
|
SECONDARY outcome
Timeframe: BaselinePopulation: All randomized participants receiving at least one dose of study drug and having baseline Charnley's Pain Scale data.
Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.
Outcome measures
| Measure |
Teriparatide
n=85 Participants
20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=85 Participants
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
5- Pain severe and spontaneous
|
5.9 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
0-No pain
|
9.4 percentage of participants
|
8.2 percentage of participants
|
|
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
1- Pain slight or intermittent
|
4.7 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
2- Pain occurs only after some activity
|
23.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
3- Pain is tolerable
|
36.5 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
4- Pain severe on attempting to walk
|
20.0 percentage of participants
|
15.3 percentage of participants
|
SECONDARY outcome
Timeframe: 6, 12, 18, and 26 WeeksPopulation: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.
Outcome measures
| Measure |
Teriparatide
n=63 Participants
20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=62 Participants
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Visual Analog Scale (VAS)
Week 6
|
16.44 millimeter (mm)
Standard Error 3.977
|
23.54 millimeter (mm)
Standard Error 4.443
|
|
Visual Analog Scale (VAS)
Week 12
|
9.28 millimeter (mm)
Standard Error 4.048
|
19.24 millimeter (mm)
Standard Error 4.452
|
|
Visual Analog Scale (VAS)
Week 18
|
6.90 millimeter (mm)
Standard Error 4.147
|
18.19 millimeter (mm)
Standard Error 4.508
|
|
Visual Analog Scale (VAS)
Week 26
|
4.48 millimeter (mm)
Standard Error 4.128
|
13.74 millimeter (mm)
Standard Error 4.505
|
SECONDARY outcome
Timeframe: 6, 12, 18, and 26 WeeksPopulation: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
Timed "Up and Go" test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score.
Outcome measures
| Measure |
Teriparatide
n=79 Participants
20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=78 Participants
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Timed "Up and Go" Test
Week 6
|
26.45 seconds (sec)
Standard Error 1.090
|
32.38 seconds (sec)
Standard Error 1.085
|
|
Timed "Up and Go" Test
Week 12
|
20.13 seconds (sec)
Standard Error 1.092
|
24.48 seconds (sec)
Standard Error 1.086
|
|
Timed "Up and Go" Test
Week 18
|
17.75 seconds (sec)
Standard Error 1.093
|
21.14 seconds (sec)
Standard Error 1.087
|
|
Timed "Up and Go" Test
Week 26
|
16.69 seconds (sec)
Standard Error 1.095
|
19.91 seconds (sec)
Standard Error 1.088
|
Adverse Events
Teriparatide
Serious events: 21 serious events
Other events: 53 other events
Deaths: 0 deaths
Risedronate
Serious events: 27 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide
n=106 participants at risk
20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=110 participants at risk
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/106
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 2
Received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
General disorders
Death
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
General disorders
Device breakage
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
General disorders
Device failure
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
General disorders
Medical device complication
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Hepatobiliary disorders
Liver disorder
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
5.7%
6/106 • Number of events 6
Received at least one dose of study drug.
|
8.2%
9/110 • Number of events 9
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
3.6%
4/110 • Number of events 4
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/106
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
3/106 • Number of events 3
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Nervous system disorders
Amnesia
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/106
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.94%
1/106 • Number of events 2
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Nervous system disorders
Monoplegia
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Nervous system disorders
Speech disorder
|
0.94%
1/106 • Number of events 2
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial polyp
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/106
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
Other adverse events
| Measure |
Teriparatide
n=106 participants at risk
20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
Risedronate
n=110 participants at risk
35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/106
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
3/106 • Number of events 3
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
2.7%
3/110 • Number of events 3
Received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/106 • Number of events 3
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/106 • Number of events 6
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
3.8%
4/106 • Number of events 4
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.6%
7/106 • Number of events 7
Received at least one dose of study drug.
|
3.6%
4/110 • Number of events 7
Received at least one dose of study drug.
|
|
Infections and infestations
Viral infection
|
2.8%
3/106 • Number of events 4
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
6.6%
7/106 • Number of events 8
Received at least one dose of study drug.
|
4.5%
5/110 • Number of events 5
Received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Investigations
Platelet count increased
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.3%
12/106 • Number of events 16
Received at least one dose of study drug.
|
6.4%
7/110 • Number of events 8
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
3/106 • Number of events 6
Received at least one dose of study drug.
|
2.7%
3/110 • Number of events 3
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/106
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
3/106 • Number of events 7
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 3
Received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
2.7%
3/110 • Number of events 3
Received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.8%
3/106 • Number of events 3
Received at least one dose of study drug.
|
0.91%
1/110 • Number of events 1
Received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/106
Received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1
Received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulval ulceration
|
0.00%
0/106
Received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
1.2%
1/81 • Number of events 1
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
2/106 • Number of events 2
Received at least one dose of study drug.
|
0.00%
0/110
Received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.94%
1/106 • Number of events 1
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
4.7%
5/106 • Number of events 5
Received at least one dose of study drug.
|
1.8%
2/110 • Number of events 2
Received at least one dose of study drug.
|
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: LTE60