Trial · NCT01225055
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
NCT01225055, Phase 2, Completed, Thomas J. Schnitzer; results first posted 2017-06-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury. Trials, record NCT01225055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01225055
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
- NCT number
- NCT01225055
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Thomas J. Schnitzer
- Conditions
- Spinal Cord Injury, Bone Loss, Osteoporosis
- Interventions
- Teriparatide, vibration
- First posted
- 2010-10-20
- Last updated
- 2025-12-02
- Results first posted
- 2017-06-22
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 DXA. | Baseline to 12 Months | The mean change in BMD of the total hip after 12 month of treatment |
| Secondary | Bone Mineral Density (BMD) by DXA at the Lumbar Spine. | Baseline to 12 Months | The mean change in BMD at the lumbar spine from baseline after 12 month of treatment |
| Secondary | Bone Mineral Density (BMD) by DXA at Femoral Neck | Baseline to 12 Months | The mean change in BMD of the femoral neck after 12 month of treatment |
| Secondary | C-terminal Telopeptide | Baseline to 12 Months | The mean change in C-terminal telopeptide from baseline after 12 month of treatment |
| Secondary | Bone-specific Alkaline Phosphatase | Baseline to 12 Months | The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy |
| Secondary | Amino-terminal Propeptide of Type 1 Collagen | Baseline to 12 Months | The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment |
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 DXA. | Baseline to 12 Months | 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. | g/cm^2 | MEAN |
| SECONDARY | Bone Mineral Density (BMD) by DXA at the Lumbar Spine. | Baseline to 12 Months | 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. | g/cm^2 | MEAN |
| SECONDARY | Bone Mineral Density (BMD) by DXA at Femoral Neck | Baseline to 12 Months | 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. | g/cm^2 | MEAN |
| SECONDARY | C-terminal Telopeptide | Baseline to 12 Months | 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. | ng/ml | MEAN |
| SECONDARY | Bone-specific Alkaline Phosphatase | Baseline to 12 Months | 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. | ng/ml | MEAN |
| SECONDARY | Amino-terminal Propeptide of Type 1 Collagen | Baseline to 12 Months | 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. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group72
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 DXA. | Teriparatide | 0 months | 0.66 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Vibration | 0 months | 0.63 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Teriparatide and Vibration | 0 months | 0.64 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Teriparatide | 3 months | 0.65 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Vibration | 3 months | 0.63 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Teriparatide and Vibration | 3 months | 0.65 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Teriparatide | 6 months | 0.67 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Vibration | 6 months | 0.63 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Teriparatide and Vibration | 6 months | 0.65 | Standard Deviation 0.03 | g/cm^2 |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | Teriparatide | 12 months | 0.66 | Standard Deviation 0.03 | g/cm^2 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 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 | 20 | |
| Overall Study | STARTED | Vibration | 20 | |
| Overall Study | STARTED | Teriparatide and Vibration | 21 | |
| Overall Study | COMPLETED | Teriparatide | 20 | |
| Overall Study | COMPLETED | Vibration | 18 | |
| Overall Study | COMPLETED | Teriparatide and Vibration | 18 | |
| Overall Study | NOT COMPLETED | Teriparatide | 0 | |
| Overall Study | NOT COMPLETED | Vibration | 2 | |
| Overall Study | NOT COMPLETED | Teriparatide and Vibration | 3 |
Source ClinicalTrials.gov
Adverse events90
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 | Acid Reflux | Gastrointestinal disorders | Teriparatide | 4 | 20 | 4 |
| other | Acid Reflux | Gastrointestinal disorders | Vibration | 0 | 20 | 0 |
| other | Acid Reflux | Gastrointestinal disorders | Teriparatide and Vibration | 0 | 20 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Teriparatide | 5 | 20 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Vibration | 1 | 20 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Teriparatide and Vibration | 4 | 20 | 6 |
| other | Bleeding, bruising or irritation at injection site | Skin and subcutaneous tissue disorders | Teriparatide | 3 | 20 | 3 |
| other | Bleeding, bruising or irritation at injection site | Skin and subcutaneous tissue disorders | Vibration | 3 | 20 | 3 |
| other | Bleeding, bruising or irritation at injection site | Skin and subcutaneous tissue disorders | Teriparatide and Vibration | 6 | 20 | 6 |
| other | Burns | Skin and subcutaneous tissue disorders | Teriparatide | 1 | 20 | 1 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | 0 | 20 |
| Total, all-cause mortality | Vibration | 0 | 20 |
| Total, all-cause mortality | Teriparatide and Vibration | 0 | 20 |
| Total, other adverse events | Teriparatide | 16 | 20 |
| Total, other adverse events | Vibration | 16 | 20 |
| Total, other adverse events | Teriparatide and Vibration | 16 | 20 |
| Total, serious adverse events | Teriparatide | 7 | 20 |
| Total, serious adverse events | Vibration | 1 | 20 |
| Total, serious adverse events | Teriparatide and Vibration | 8 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30334093 | DERIVED |
Source PubMed
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/NCT01225055
GET https://conductscience.org/api/trials/v1/NCT01225055/results?page=2