Trial Outcomes & Findings for Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury (NCT NCT01225055)
NCT ID: NCT01225055
Last Updated: 2025-12-02
Results Overview
The mean change in BMD of the total hip after 12 month of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline to 12 Months
Results posted on
2025-12-02
Participant Flow
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. After consenting the subject did not participate in the study.. This accounts for the 61 in Participant Flow but 60 that were enrolled and started treatment according to their assigned group.
Participant milestones
| Measure |
Teriparatide
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Teriparatide
n=20 Participants
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=20 Participants
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=21 Participants
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=121 Participants
|
18 Participants
n=122 Participants
|
19 Participants
n=243 Participants
|
53 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
8 Participants
n=24 Participants
|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 16.3 • n=121 Participants
|
40.9 years
STANDARD_DEVIATION 16.4 • n=122 Participants
|
46.6 years
STANDARD_DEVIATION 15.4 • n=243 Participants
|
45.4 years
STANDARD_DEVIATION 16.3 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
5 Participants
n=243 Participants
|
14 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=121 Participants
|
14 Participants
n=122 Participants
|
16 Participants
n=243 Participants
|
47 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=121 Participants
|
4 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
16 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=121 Participants
|
16 Participants
n=122 Participants
|
15 Participants
n=243 Participants
|
45 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=121 Participants
|
10 Participants
n=122 Participants
|
14 Participants
n=243 Participants
|
33 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=121 Participants
|
7 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
25 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=121 Participants
|
20 participants
n=122 Participants
|
21 participants
n=243 Participants
|
60 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 MonthsPopulation: One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Two additional subjects were not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 14 subjects that were not analyzed.
The mean change in BMD of the total hip after 12 month of treatment
Outcome measures
| Measure |
Teriparatide and Vibration
n=15 Participants
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
Teriparatide
n=15 Participants
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=17 Participants
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
0 months
|
0.64 g/cm^2
Standard Deviation 0.03
|
0.66 g/cm^2
Standard Deviation 0.03
|
0.63 g/cm^2
Standard Deviation 0.03
|
|
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
3 months
|
0.65 g/cm^2
Standard Deviation 0.03
|
0.65 g/cm^2
Standard Deviation 0.03
|
0.63 g/cm^2
Standard Deviation 0.03
|
|
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
6 months
|
0.65 g/cm^2
Standard Deviation 0.03
|
0.67 g/cm^2
Standard Deviation 0.03
|
0.63 g/cm^2
Standard Deviation 0.03
|
|
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
12 months
|
0.65 g/cm^2
Standard Deviation 0.03
|
0.66 g/cm^2
Standard Deviation 0.03
|
0.64 g/cm^2
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Five additional subjects were not analyzed due to metal artifacts that interfered with analysis. This accounts for the 17 subjects that were not analyzed.
The mean change in BMD at the lumbar spine from baseline after 12 month of treatment
Outcome measures
| Measure |
Teriparatide and Vibration
n=14 Participants
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
Teriparatide
n=16 Participants
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=14 Participants
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
0 months
|
1.02 g/cm^2
Standard Deviation 0.04
|
1.04 g/cm^2
Standard Deviation 0.04
|
1.00 g/cm^2
Standard Deviation 0.04
|
|
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
3 months
|
1.04 g/cm^2
Standard Deviation 0.04
|
1.05 g/cm^2
Standard Deviation 0.04
|
1.01 g/cm^2
Standard Deviation 0.04
|
|
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
6 months
|
1.05 g/cm^2
Standard Deviation 0.04
|
1.07 g/cm^2
Standard Deviation 0.04
|
1.02 g/cm^2
Standard Deviation 0.04
|
|
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
12 months
|
1.07 g/cm^2
Standard Deviation 0.04
|
1.09 g/cm^2
Standard Deviation 0.04
|
1.02 g/cm^2
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. One additional subjects was not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 13 subjects that were not analyzed.
The mean change in BMD of the femoral neck after 12 month of treatment
Outcome measures
| Measure |
Teriparatide and Vibration
n=16 Participants
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
Teriparatide
n=15 Participants
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=17 Participants
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Bone Mineral Density (BMD) by DXA at Femoral Neck
3 months
|
0.63 g/cm^2
Standard Deviation 0.04
|
0.66 g/cm^2
Standard Deviation 0.04
|
0.64 g/cm^2
Standard Deviation 0.04
|
|
Bone Mineral Density (BMD) by DXA at Femoral Neck
6 months
|
0.63 g/cm^2
Standard Deviation 0.04
|
0.67 g/cm^2
Standard Deviation 0.04
|
0.62 g/cm^2
Standard Deviation 0.03
|
|
Bone Mineral Density (BMD) by DXA at Femoral Neck
12 months
|
0.63 g/cm^2
Standard Deviation 0.03
|
0.66 g/cm^2
Standard Deviation 0.03
|
0.63 g/cm^2
Standard Deviation 0.03
|
|
Bone Mineral Density (BMD) by DXA at Femoral Neck
0 months
|
0.62 g/cm^2
Standard Deviation 0.03
|
0.66 g/cm^2
Standard Deviation 0.03
|
0.63 g/cm^2
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.
The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Outcome measures
| Measure |
Teriparatide and Vibration
n=16 Participants
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
Teriparatide
n=15 Participants
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=17 Participants
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
C-terminal Telopeptide
0 months
|
0.38 ng/ml
Standard Deviation 0.06
|
0.38 ng/ml
Standard Deviation 0.07
|
0.31 ng/ml
Standard Deviation 0.06
|
|
C-terminal Telopeptide
3 months
|
0.43 ng/ml
Standard Deviation 0.11
|
0.72 ng/ml
Standard Deviation 0.11
|
0.25 ng/ml
Standard Deviation 0.10
|
|
C-terminal Telopeptide
6 months
|
0.44 ng/ml
Standard Deviation 0.11
|
0.74 ng/ml
Standard Deviation 0.11
|
0.25 ng/ml
Standard Deviation 0.11
|
|
C-terminal Telopeptide
12 months
|
0.45 ng/ml
Standard Deviation 0.11
|
0.59 ng/ml
Standard Deviation 0.11
|
0.29 ng/ml
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.
The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy
Outcome measures
| Measure |
Teriparatide and Vibration
n=16 Participants
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
Teriparatide
n=15 Participants
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=17 Participants
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Bone-specific Alkaline Phosphatase
0 months
|
12.4 ng/ml
Standard Deviation 1.58
|
15.3 ng/ml
Standard Deviation 1.63
|
13.9 ng/ml
Standard Deviation 1.53
|
|
Bone-specific Alkaline Phosphatase
3 months
|
12.8 ng/ml
Standard Deviation 1.75
|
18.4 ng/ml
Standard Deviation 1.81
|
11.6 ng/ml
Standard Deviation 1.70
|
|
Bone-specific Alkaline Phosphatase
6 months
|
16.2 ng/ml
Standard Deviation 2.56
|
20.3 ng/ml
Standard Deviation 2.64
|
11.3 ng/ml
Standard Deviation 2.48
|
|
Bone-specific Alkaline Phosphatase
12 months
|
14.0 ng/ml
Standard Deviation 1.53
|
20.4 ng/ml
Standard Deviation 1.58
|
11.8 ng/ml
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.
The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment
Outcome measures
| Measure |
Teriparatide and Vibration
n=16 Participants
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
Teriparatide
n=15 Participants
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=17 Participants
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Amino-terminal Propeptide of Type 1 Collagen
0 months
|
67.9 ng/ml
Standard Deviation 8.61
|
67.1 ng/ml
Standard Deviation 8.90
|
64.7 ng/ml
Standard Deviation 8.36
|
|
Amino-terminal Propeptide of Type 1 Collagen
3 months
|
90.1 ng/ml
Standard Deviation 12.5
|
128 ng/ml
Standard Deviation 12.9
|
51.8 ng/ml
Standard Deviation 12.1
|
|
Amino-terminal Propeptide of Type 1 Collagen
6 months
|
125 ng/ml
Standard Deviation 29.4
|
163 ng/ml
Standard Deviation 30.4
|
54.5 ng/ml
Standard Deviation 28.6
|
|
Amino-terminal Propeptide of Type 1 Collagen
12 months
|
77.0 ng/ml
Standard Deviation 13.0
|
124 ng/ml
Standard Deviation 13.5
|
49.8 ng/ml
Standard Deviation 12.7
|
Adverse Events
Teriparatide
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Vibration
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Teriparatide and Vibration
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide
n=20 participants at risk
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=20 participants at risk
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=20 participants at risk
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Cardiac disorders
Cardiovascular Event
|
5.0%
1/20 • Number of events 3 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity fracture
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia and respiratory distress
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Skin and subcutaneous tissue disorders
Soft tissue infection
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Renal and urinary disorders
Urinary tract infection
|
20.0%
4/20 • Number of events 5 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 8 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
Other adverse events
| Measure |
Teriparatide
n=20 participants at risk
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=20 participants at risk
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=20 participants at risk
Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Gastrointestinal disorders
Acid Reflux
|
20.0%
4/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
5/20 • Number of events 6 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
20.0%
4/20 • Number of events 6 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Skin and subcutaneous tissue disorders
Bleeding, bruising or irritation at injection site
|
15.0%
3/20 • Number of events 3 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
15.0%
3/20 • Number of events 3 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
30.0%
6/20 • Number of events 6 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Skin and subcutaneous tissue disorders
Burns
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
4/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
25.0%
5/20 • Number of events 5 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
25.0%
5/20 • Number of events 5 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
15.0%
3/20 • Number of events 3 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
35.0%
7/20 • Number of events 8 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Infections and infestations
Flu like symptoms
|
25.0%
5/20 • Number of events 6 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
15.0%
3/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
20.0%
4/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Nervous system disorders
Increased Nerve Pain
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 3 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Nervous system disorders
Increased spasticity
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Injury, poisoning and procedural complications
Injury
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
15.0%
3/20 • Number of events 5 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
20.0%
4/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity fractures
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 1 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity pain
|
20.0%
4/20 • Number of events 5 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
5.0%
1/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Gastrointestinal disorders
Nausea/Vomitting
|
20.0%
4/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
15.0%
3/20 • Number of events 3 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
20.0%
4/20 • Number of events 5 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Gastrointestinal disorders
Parageusia
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Nervous system disorders
Parathesias
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Skin and subcutaneous tissue disorders
Pressure sore
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
15.0%
3/20 • Number of events 7 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
0.00%
0/20 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
10.0%
2/20 • Number of events 2 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
30.0%
6/20 • Number of events 6 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
25.0%
5/20 • Number of events 6 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
25.0%
5/20 • Number of events 6 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
|
Renal and urinary disorders
Urinary tract infection
|
45.0%
9/20 • Number of events 11 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
15.0%
3/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
20.0%
4/20 • Number of events 4 • Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place