Trial Outcomes & Findings for Second Study of the Effect of Teriparatide on Hip Fracture Healing (NCT NCT01473602)
NCT ID: NCT01473602
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.
COMPLETED
PHASE3
39 participants
12 months
2015-04-16
Participant Flow
Participant milestones
| Measure |
Teriparatide
Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
21
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
18
|
20
|
|
Overall Study
Completed 6 Months
|
12
|
15
|
|
Overall Study
Completed 12 Months
|
10
|
13
|
|
Overall Study
COMPLETED
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Teriparatide
Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Second Study of the Effect of Teriparatide on Hip Fracture Healing
Baseline characteristics by cohort
| Measure |
Teriparatide
n=18 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=20 Participants
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.39 years
STANDARD_DEVIATION 10.259 • n=5 Participants
|
69.93 years
STANDARD_DEVIATION 10.417 • n=7 Participants
|
71.57 years
STANDARD_DEVIATION 10.351 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 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
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 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
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Surgical screw type
Cancellous Screws
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Surgical screw type
Sliding Hip Screws
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants who were randomized, 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=18 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=20 Participants
Placebo 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
|
74 Percentage of participants
Interval 51.0 to 88.0
|
93 Percentage of participants
Interval 70.0 to 99.0
|
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 and healing complications 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=18 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=20 Participants
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants With Radiographic Evidence of Healing
|
55.6 Percentage of participants
|
65.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 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. Higher scores indicated more severe pain. Participants with an NRS score of \<7 and no worsening of NRS scores \>2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) \* 100.
Outcome measures
| Measure |
Teriparatide
n=10 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=13 Participants
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants With Pain Control During Ambulation
|
90.0 Percentage of participants
|
100.0 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 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 score \>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 analyzed) \* 100.
Outcome measures
| Measure |
Teriparatide
n=11 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=14 Participants
Placebo 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
|
81.8 Percentage of participants
|
92.9 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.
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 score \>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=11 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=13 Participants
Placebo 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
|
90.9 Percentage of participants
|
84.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 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=13 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=15 Participants
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants With Functional Evidence of Healing
|
76.9 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who were randomized, received treatment and had at least 1 nonmissing post-baseline measurement. LOCF values used
Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) \* 100.
Outcome measures
| Measure |
Teriparatide
n=13 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=15 Participants
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants Able to Ambulate
|
76.9 Percentage of participants
|
93.3 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 of participants analyzed) \*100.
Outcome measures
| Measure |
Teriparatide
n=17 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=16 Participants
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Percentage of Participants Who Regained Their Prefracture Ambulatory Status
|
47.1 Percentage of participants
|
62.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Participants who were randomized, received at least 1 dose of study drug, 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) adjusted for baseline, treatment group, region, fracture type, and fixation type.
Outcome measures
| Measure |
Teriparatide
n=18 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=20 Participants
Placebo 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= 10, 13)
|
-1.6 Units on a scale
Standard Error 1.46
|
-1.3 Units on a scale
Standard Error 1.45
|
|
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
During 24 hours preceding visit (n= 10, 14)
|
-1.2 Units on a scale
Standard Error 1.27
|
-1.4 Units on a scale
Standard Error 1.21
|
|
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
On weight bearing (n= 10, 13)
|
-2.0 Units on a scale
Standard Error 1.50
|
-1.4 Units on a scale
Standard Error 1.45
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 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 adjusted for baseline, treatment group, region, fracture type, and fixation type
Outcome measures
| Measure |
Teriparatide
n=10 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=13 Participants
Placebo 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
|
0.168 m/s
Standard Error 0.153
|
0.118 m/s
Standard Error 0.145
|
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 = 14; placebo = 19.
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=18 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=20 Participants
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|
|
Time to Revision Surgery
|
333.5 Days
Interval 35.0 to 443.0
|
361 Days
Interval 29.0 to 426.0
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Participants who were randomized, received treatment, 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 means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Teriparatide
n=18 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=20 Participants
Placebo 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=12, 14)
|
0.89 Units on a scale
Standard Error 3.0
|
1.78 Units on a scale
Standard Error 2.75
|
|
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=12, 14)
|
-8.84 Units on a scale
Standard Error 5.80
|
-10.71 Units on a scale
Standard Error 5.14
|
SECONDARY outcome
Timeframe: Baseline, up to 6 MonthsPopulation: Participants who were randomized, received treatment, 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: was 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. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Outcome measures
| Measure |
Teriparatide
n=18 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=20 Participants
Placebo 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=11, 12)
|
10.5 Units on a scale
Standard Error 12.41
|
1.1 Units on a scale
Standard Error 12.42
|
|
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Pain Score - Month 6 (n=12, 13)
|
10.6 Units on a scale
Standard Error 10.64
|
13.6 Units on a scale
Standard Error 10.09
|
|
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Stiffness Score - Month 6 (n=12, 15)
|
13.5 Units on a scale
Standard Error 8.71
|
16.9 Units on a scale
Standard Error 7.74
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Participants who were randomized, received treatment, 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 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region.
Outcome measures
| Measure |
Teriparatide
n=18 Participants
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo
n=20 Participants
Placebo 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) Overall Health Score
|
13.0 Units on a scale
Standard Error 6.42
|
10.4 Units on a scale
Standard Error 6.67
|
Adverse Events
Placebo
Teriparatide
Placebo Follow-up
Teriparatide Follow-up
Serious adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Teriparatide
n=18 participants at risk
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo Follow-up
n=15 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=12 participants at risk
Follow-up after teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
8.3%
1/12 • Number of events 1 • Randomization to Study Completion
|
|
Infections and infestations
Osteomyelitis
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Injury, poisoning and procedural complications
Femur fracture
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Investigations
Blood glucose fluctuation
|
0.00%
0/20 • Randomization to Study Completion
|
5.6%
1/18 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
8.3%
1/12 • Number of events 1 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
|
Teriparatide
n=18 participants at risk
Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
Placebo Follow-up
n=15 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=12 participants at risk
Follow-up after teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/20 • Randomization to Study Completion
|
5.6%
1/18 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
General disorders
Fatigue
|
0.00%
0/20 • Randomization to Study Completion
|
5.6%
1/18 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Infections and infestations
Vulvovaginal candidiasis
|
6.2%
1/16 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/14 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
0.00%
0/9 • Randomization to Study Completion
|
|
Investigations
Blood cholesterol increased
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Investigations
Bone density decreased
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • Randomization to Study Completion
|
5.6%
1/18 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
8.3%
1/12 • Number of events 1 • Randomization to Study Completion
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Nervous system disorders
Multiple system atrophy
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
8.3%
1/12 • Number of events 1 • Randomization to Study Completion
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
8.3%
1/12 • Number of events 1 • Randomization to Study Completion
|
|
Nervous system disorders
Sciatica
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Psychiatric disorders
Sleep disorder
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Surgical and medical procedures
Bladder catheterisation
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 2 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
8.3%
1/12 • Number of events 1 • Randomization to Study Completion
|
|
Surgical and medical procedures
Wisdom teeth removal
|
5.0%
1/20 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Surgical and medical procedures
Wrist surgery
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
6.7%
1/15 • Number of events 1 • Randomization to Study Completion
|
0.00%
0/12 • Randomization to Study Completion
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
8.3%
1/12 • Number of events 1 • Randomization to Study Completion
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/20 • Randomization to Study Completion
|
0.00%
0/18 • Randomization to Study Completion
|
0.00%
0/15 • Randomization to Study Completion
|
8.3%
1/12 • Number of events 1 • Randomization to Study Completion
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60