Trial Outcomes & Findings for 12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI) (NCT NCT02025179)
NCT ID: NCT02025179
Last Updated: 2023-05-10
Results Overview
The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline to 24 months
Results posted on
2023-05-10
Participant Flow
Participant milestones
| Measure |
Teriparatide
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Teriparatide
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
Baseline characteristics by cohort
| Measure |
Teriparatide
n=8 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=8 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
n=99 Participants
|
38.0 years
n=107 Participants
|
41.7 years
n=206 Participants
|
40.5 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale
ASIA A (Complete Injury)
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale
ASIA B (Sensory Incomplete Injury)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale
ASIA C (Motor Incomplete Injury)
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale
ASIA D (Motor Incomplete Injury)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 monthsPopulation: One subject in "Teriparatide and vibration" group was lost to follow-up
The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Outcome measures
| Measure |
Teriparatide
n=8 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=7 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)
|
6.73 Percent change
Interval 3.37 to 10.1
|
-0.34 Percent change
Interval -3.5 to 2.82
|
4.24 Percent change
Interval 0.37 to 8.11
|
SECONDARY outcome
Timeframe: Baseline to 24 MonthsPopulation: One subject in "Teriparatide and vibration" group was lost to follow-up
The mean percent change in C-terminal telopeptide from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Outcome measures
| Measure |
Teriparatide
n=8 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=7 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
C-terminal Telopeptide
|
-19.8 Percent change
Interval -69.0 to 29.5
|
-14.8 Percent change
Interval -61.2 to 31.6
|
-2.12 Percent change
Interval -54.8 to 50.5
|
SECONDARY outcome
Timeframe: Baseline to 24 MonthsPopulation: One subject in "Teriparatide and vibration" group was lost to follow-up. Another subject in "Teriparatide and vibration" spine could not be analyzed due to a baclofen pump.
The mean percent change in BMD at the lumbar spine from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Outcome measures
| Measure |
Teriparatide
n=8 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=6 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Bone Mineral Density (BMD) by DXA at the Lumbar Spine
|
14.4 Percent change
Interval 11.0 to 17.8
|
7.05 Percent change
Interval 3.87 to 10.2
|
8.98 Percent change
Interval 5.08 to 12.9
|
SECONDARY outcome
Timeframe: Baseline to 24 MonthsPopulation: One subject in "Teriparatide and vibration" group was lost to follow-up
The mean percent change in BMD of the femoral neck after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Outcome measures
| Measure |
Teriparatide
n=8 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=7 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Bone Mineral Density (BMD) by DXA at Femoral Neck
|
2.73 Percent change
Interval -2.81 to 8.26
|
-0.06 Percent change
Interval -5.28 to 5.16
|
4.71 Percent change
Interval -1.2 to 10.6
|
SECONDARY outcome
Timeframe: Baseline to 24 MonthsPopulation: One subject in "Teriparatide and vibration" group was lost to follow-up
The mean percent change in Amino-terminal of type 1 collagen from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Outcome measures
| Measure |
Teriparatide
n=8 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=7 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Amino-terminal Propeptide of Type 1 Collagen
|
102 Percent change
Interval 73.0 to 132.0
|
104 Percent change
Interval 76.6 to 132.0
|
58 Percent change
Interval 26.6 to 89.5
|
SECONDARY outcome
Timeframe: Baseline to 24 MonthsPopulation: One subject in "Teriparatide and vibration" group was lost to follow-up
The mean percent change in Bone-specific alkaline phosphatase from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Outcome measures
| Measure |
Teriparatide
n=8 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=7 Participants
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Bone-specific Alkaline Phosphatase
|
11.5 Percent change
Interval 9.04 to 14.0
|
12.6 Percent change
Interval 10.3 to 14.9
|
10.9 Percent change
Interval 8.3 to 13.6
|
Adverse Events
Teriparatide
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vibration
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Teriparatide and Vibration
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide
n=8 participants at risk
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 participants at risk
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=7 participants at risk
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 2 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
General disorders
Dehydration
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Renal and urinary disorders
Kidney Stone
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
Other adverse events
| Measure |
Teriparatide
n=8 participants at risk
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
|
Vibration
n=9 participants at risk
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months
|
Teriparatide and Vibration
n=7 participants at risk
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide with vibration applied in conjunction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
28.6%
2/7 • Number of events 2 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Skin and subcutaneous tissue disorders
Acne
|
25.0%
2/8 • Number of events 2 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Immune system disorders
Allergic Reaction
|
12.5%
1/8 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Immune system disorders
Allergies
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Infections and infestations
Cold/Flu
|
25.0%
2/8 • Number of events 3 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
22.2%
2/9 • Number of events 2 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
28.6%
2/7 • Number of events 3 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Injury, poisoning and procedural complications
Cut
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
General disorders
Dizziness
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Skin and subcutaneous tissue disorders
Dry scalp
|
12.5%
1/8 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
General disorders
Fall
|
12.5%
1/8 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
General disorders
Fatigue
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Gastrointestinal disorders
Food poisoning
|
12.5%
1/8 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
22.2%
2/9 • Number of events 2 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Cardiac disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Renal and urinary disorders
Hyponatremia
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Injury, poisoning and procedural complications
Lower extremity fracture
|
12.5%
1/8 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 2 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
37.5%
3/8 • Number of events 3 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
42.9%
3/7 • Number of events 6 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Nervous system disorders
Pinched nerve
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 2 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Skin and subcutaneous tissue disorders
Pressure sore
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
28.6%
2/7 • Number of events 3 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Injury, poisoning and procedural complications
Toe wound
|
12.5%
1/8 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/9 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
0.00%
0/7 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/8 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
11.1%
1/9 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
14.3%
1/7 • Number of events 1 • 12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place