Trial · NCT02025179
12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
NCT02025179, Phase 2, Completed, Northwestern University; results first posted 2018-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI). Trials, record NCT02025179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02025179
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
- NCT number
- NCT02025179
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Spinal Cord Injury, Bone Loss, Osteoporosis
- Interventions
- Teriparatide, Vibration
- First posted
- 2013-12-31
- Last updated
- 2023-05-10
- Results first posted
- 2018-09-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) | Baseline to 24 months | 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). |
| Secondary | C-terminal Telopeptide | Baseline to 24 Months | 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). |
| Secondary | Bone Mineral Density (BMD) by DXA at the Lumbar Spine | Baseline to 24 Months | 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). |
| Secondary | Bone Mineral Density (BMD) by DXA at Femoral Neck | Baseline to 24 Months | 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). |
| Secondary | Amino-terminal Propeptide of Type 1 Collagen | Baseline to 24 Months | 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). |
| Secondary | Bone-specific Alkaline Phosphatase | Baseline to 24 Months | 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). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) | Baseline to 24 months | One subject in Teriparatide and vibration group was lost to follow-up | Percent change | MEAN |
| SECONDARY | C-terminal Telopeptide | Baseline to 24 Months | One subject in Teriparatide and vibration group was lost to follow-up | Percent change | MEAN |
| SECONDARY | Bone Mineral Density (BMD) by DXA at the Lumbar Spine | Baseline to 24 Months | 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. | Percent change | MEAN |
| SECONDARY | Bone Mineral Density (BMD) by DXA at Femoral Neck | Baseline to 24 Months | One subject in Teriparatide and vibration group was lost to follow-up | Percent change | MEAN |
| SECONDARY | Amino-terminal Propeptide of Type 1 Collagen | Baseline to 24 Months | One subject in Teriparatide and vibration group was lost to follow-up | Percent change | MEAN |
| SECONDARY | Bone-specific Alkaline Phosphatase | Baseline to 24 Months | One subject in Teriparatide and vibration group was lost to follow-up | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) | Teriparatide | 6.73 | 95% Confidence Interval 3.37 to 10.1 | Percent change | |
| Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) | Vibration | -0.34 | 95% Confidence Interval -3.50 to 2.82 | Percent change | |
| Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) | Teriparatide and Vibration | 4.24 | 95% Confidence Interval 0.37 to 8.11 | Percent change | |
| C-terminal Telopeptide | Teriparatide | -19.8 | 95% Confidence Interval -69.0 to 29.5 | Percent change | |
| C-terminal Telopeptide | Vibration | -14.8 | 95% Confidence Interval -61.2 to 31.6 | Percent change | |
| C-terminal Telopeptide | Teriparatide and Vibration | -2.12 | 95% Confidence Interval -54.8 to 50.5 | Percent change | |
| Bone Mineral Density (BMD) by DXA at the Lumbar Spine | Teriparatide | 14.4 | 95% Confidence Interval 11.0 to 17.8 | Percent change | |
| Bone Mineral Density (BMD) by DXA at the Lumbar Spine | Vibration | 7.05 | 95% Confidence Interval 3.87 to 10.2 | Percent change | |
| Bone Mineral Density (BMD) by DXA at the Lumbar Spine | Teriparatide and Vibration | 8.98 | 95% Confidence Interval 5.08 to 12.9 | Percent change | |
| Bone Mineral Density (BMD) by DXA at Femoral Neck | Teriparatide | 2.73 | 95% Confidence Interval -2.81 to 8.26 | Percent change |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 8 | |
| Overall Study | STARTED | Vibration | 9 | |
| Overall Study | STARTED | Teriparatide and Vibration | 8 | |
| Overall Study | COMPLETED | Teriparatide | 8 | |
| Overall Study | COMPLETED | Vibration | 9 | |
| Overall Study | COMPLETED | Teriparatide and Vibration | 7 | |
| Overall Study | NOT COMPLETED | Teriparatide | 0 | |
| Overall Study | NOT COMPLETED | Vibration | 0 | |
| Overall Study | NOT COMPLETED | Teriparatide and Vibration | 1 |
Source ClinicalTrials.gov
Adverse events87
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Teriparatide | 0 | 8 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Vibration | 1 | 9 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Teriparatide and Vibration | 2 | 7 | 2 |
| other | Acne | Skin and subcutaneous tissue disorders | Teriparatide | 2 | 8 | 2 |
| other | Acne | Skin and subcutaneous tissue disorders | Vibration | 0 | 9 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Teriparatide and Vibration | 0 | 7 | 0 |
| other | Allergic Reaction | Immune system disorders | Teriparatide | 1 | 8 | 1 |
| other | Allergic Reaction | Immune system disorders | Vibration | 1 | 9 | 1 |
| other | Allergic Reaction | Immune system disorders | Teriparatide and Vibration | 0 | 7 | 0 |
| other | Allergies | Immune system disorders | Teriparatide | 0 | 8 | 0 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | 0 | 8 |
| Total, all-cause mortality | Vibration | 0 | 9 |
| Total, all-cause mortality | Teriparatide and Vibration | 0 | 7 |
| Total, other adverse events | Teriparatide | 5 | 8 |
| Total, other adverse events | Vibration | 7 | 9 |
| Total, other adverse events | Teriparatide and Vibration | 5 | 7 |
| Total, serious adverse events | Teriparatide | 0 | 8 |
| Total, serious adverse events | Vibration | 1 | 9 |
| Total, serious adverse events | Teriparatide and Vibration | 2 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02025179
GET https://conductscience.org/api/trials/v1/NCT02025179/events?page=2