Trial Outcomes & Findings for FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI) (NCT NCT01426555)
NCT ID: NCT01426555
Last Updated: 2016-04-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
70 participants
Primary outcome timeframe
12 months
Results posted on
2016-04-11
Participant Flow
Participant milestones
| Measure |
Rowing Arm
Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.
In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.
All subjects received a daily minimum supplementation of 1000mg Calcium \& 1000 IUs of Vitamin-D supplementation during the duration of the program.
|
ZA Infusion Arm
Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.
In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.
After the observation period, subjects in the FES rowing plus zoledronic acid arm were planned to receive Zoledronic Acid (Reclast ®) administered as a dose of 5mg intravenously.
All subjects received a daily minimum supplementation of 1000mg Calcium \& 1000 IUs of Vitamin-D supplementation during the duration of the program.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)
Baseline characteristics by cohort
| Measure |
ZA Infusion Arm
n=35 Participants
Thirty five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
|
Rowing Arm
n=35 Participants
Thirty five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.2 Years
n=5 Participants
|
39.0 Years
n=7 Participants
|
38.1 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data was never analyzed because the study was closed by the VABHS IRB. Full dataset is unavailable for analysis.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB.
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.
Outcome measures
Outcome data not reported
Adverse Events
ZA Infusion Arm
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Rowing Arm
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZA Infusion Arm
n=26 participants at risk
No adverse event data were available for the remaining 9 participants.
|
Rowing Arm
n=19 participants at risk
No adverse event data were available for the remaining 16 participants.
|
|---|---|---|
|
Renal and urinary disorders
UTI
|
7.7%
2/26 • Number of events 2 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
5.3%
1/19 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Renal and urinary disorders
Kidney Stone
|
3.8%
1/26 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
5.3%
1/19 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.8%
1/26 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
0.00%
0/19 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/26 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
5.3%
1/19 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Cardiac disorders
Elevated Heart Rate
|
0.00%
0/26 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
5.3%
1/19 • Number of events 2 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Infections and infestations
High Fever
|
3.8%
1/26 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
5.3%
1/19 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Skin and subcutaneous tissue disorders
Pressure Ulcers
|
0.00%
0/26 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
5.3%
1/19 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
3.8%
1/26 • Number of events 1 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
0.00%
0/19 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
Other adverse events
| Measure |
ZA Infusion Arm
n=26 participants at risk
No adverse event data were available for the remaining 9 participants.
|
Rowing Arm
n=19 participants at risk
No adverse event data were available for the remaining 16 participants.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Spasticity
|
19.2%
5/26 • Number of events 10 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
10.5%
2/19 • Number of events 2 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
General disorders
Fatigue / Not Feeling Well / Asthenia
|
23.1%
6/26 • Number of events 13 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
31.6%
6/19 • Number of events 20 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Injury, poisoning and procedural complications
Injury / Skin Cuts
|
11.5%
3/26 • Number of events 11 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
10.5%
2/19 • Number of events 2 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
15.4%
4/26 • Number of events 4 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
10.5%
2/19 • Number of events 2 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Cardiac disorders
Blood Pressure
|
15.4%
4/26 • Number of events 6 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
10.5%
2/19 • Number of events 8 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
19.2%
5/26 • Number of events 5 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
36.8%
7/19 • Number of events 14 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Cardiac disorders
Cardiac Conditions / Arrhythmias
|
11.5%
3/26 • Number of events 7 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
21.1%
4/19 • Number of events 5 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness/Disorder
|
19.2%
5/26 • Number of events 7 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
26.3%
5/19 • Number of events 9 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Musculoskeletal and connective tissue disorders
Pain / Aches / Neuralgia
|
30.8%
8/26 • Number of events 29 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
47.4%
9/19 • Number of events 24 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
General disorders
Fever
|
19.2%
5/26 • Number of events 5 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
15.8%
3/19 • Number of events 3 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Injury, poisoning and procedural complications
Falls / Injuries
|
38.5%
10/26 • Number of events 11 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
42.1%
8/19 • Number of events 11 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Skin and subcutaneous tissue disorders
Pressure Ulcer / Sore
|
19.2%
5/26 • Number of events 5 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
21.1%
4/19 • Number of events 4 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
19.2%
5/26 • Number of events 7 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
31.6%
6/19 • Number of events 11 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
|
General disorders
Autonomic Dysreflexia / Other General Symptoms
|
19.2%
5/26 • Number of events 12 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
42.1%
8/19 • Number of events 10 • Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place