Trial · NCT01426555
FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)
NCT01426555, Phase 2, Phase 3, Terminated, Antonio Lazzari; results first posted 2016-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI). Trials, record NCT01426555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01426555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)
- NCT number
- NCT01426555
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 70 participants, actual
- Lead sponsor
- Antonio Lazzari
- Conditions
- Osteoporosis
- Interventions
- FES-Rowing, Zoledronic acid
- First posted
- 2011-08-31
- Last updated
- 2016-04-11
- Results first posted
- 2016-03-10
- Limitations and caveats
- No Data Safety Monitor Board established for this project. Incomplete data set and analysis.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure | 12 months | This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid. |
| Secondary | Validation of DXA Scanning in Patients With SCI | 12 months | This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure | 12 months | Data was never analyzed because the study was closed by the VABHS IRB. Full dataset is unavailable for analysis. | ||
| SECONDARY | Validation of DXA Scanning in Patients With SCI | 12 months | Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rowing Arm | 35 | |
| Overall Study | STARTED | ZA Infusion Arm | 35 | |
| Overall Study | COMPLETED | Rowing Arm | 17 | |
| Overall Study | COMPLETED | ZA Infusion Arm | 20 | |
| Overall Study | NOT COMPLETED | Rowing Arm | 18 | |
| Overall Study | NOT COMPLETED | ZA Infusion Arm | 15 |
Source ClinicalTrials.gov
Adverse events44
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 | Spasticity | Musculoskeletal and connective tissue disorders | ZA Infusion Arm | 5 | 26 | 10 |
| other | Spasticity | Musculoskeletal and connective tissue disorders | Rowing Arm | 2 | 19 | 2 |
| other | Fatigue / Not Feeling Well / Asthenia | General disorders | ZA Infusion Arm | 6 | 26 | 13 |
| other | Fatigue / Not Feeling Well / Asthenia | General disorders | Rowing Arm | 6 | 19 | 20 |
| other | Injury / Skin Cuts | Injury, poisoning and procedural complications | ZA Infusion Arm | 3 | 26 | 11 |
| other | Injury / Skin Cuts | Injury, poisoning and procedural complications | Rowing Arm | 2 | 19 | 2 |
| other | Fracture | Musculoskeletal and connective tissue disorders | ZA Infusion Arm | 4 | 26 | 4 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Rowing Arm | 2 | 19 | 2 |
| other | Blood Pressure | Cardiac disorders | ZA Infusion Arm | 4 | 26 | 6 |
| other | Blood Pressure | Cardiac disorders | Rowing Arm | 2 | 19 | 8 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZA Infusion Arm | ||
| Total, all-cause mortality | Rowing Arm | ||
| Total, other adverse events | ZA Infusion Arm | 15 | 26 |
| Total, other adverse events | Rowing Arm | 15 | 19 |
| Total, serious adverse events | ZA Infusion Arm | 6 | 26 |
| Total, serious adverse events | Rowing Arm | 6 | 19 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ZA Infusion Arm vs Rowing Arm: serious adverse events |
Source Trial comparisons
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/NCT01426555
GET https://conductscience.org/api/trials/v1/NCT01426555/events?page=2