Trial Outcomes & Findings for The Relationship Between Irisin and Bone Health in Individuals With Spinal Cord Injury (NCT NCT05319522)
NCT ID: NCT05319522
Last Updated: 2026-09-01
Results Overview
Circulating irisin concentration correlated with trabecular volumetric bone mineral density at the distal tibia (4% site) in individuals with SCI and controls
COMPLETED
NA
11 participants
Baseline; at rest
2026-09-01
Participant Flow
Participant milestones
| Measure |
Individuals With SCI
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Individuals With SCI
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Phlebotomy Issue
|
1
|
0
|
Baseline Characteristics
The Relationship Between Irisin and Bone Health in Individuals With Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Individuals With SCI
n=5 Participants
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 Participants
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 Years
STANDARD_DEVIATION 9.1 • n=14 Participants
|
50.3 Years
STANDARD_DEVIATION 8.2 • n=36 Participants
|
52.5 Years
STANDARD_DEVIATION 8.2 • n=324 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
7 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
6 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
8 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
PRIMARY outcome
Timeframe: Baseline; at restPopulation: The correlations were analyzed separately for the Individuals with SCI group and the Controls group. Analyses were intended to determine if the correlation between the trabecular vBMD and irisin was significant in each group, not to compare the correlations between groups. Given the sample size of the Controls group (n=3), the results should be interpreted with caution.
Circulating irisin concentration correlated with trabecular volumetric bone mineral density at the distal tibia (4% site) in individuals with SCI and controls
Outcome measures
| Measure |
Individuals With SCI
n=5 Participants
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 Participants
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Irisin-Trabecular vBMD Correlation
|
0.178 Pearson Correlation Coefficient
|
-0.999 Pearson Correlation Coefficient
|
PRIMARY outcome
Timeframe: Baseline; at restPopulation: The correlations were analyzed separately for the Individuals with SCI group and the Controls group. Analyses were intended to determine if the correlation between the cortical vBMD and irisin was significant in each group, not to compare the correlations between groups. Given the sample size of the Controls group (n=3), the results should be interpreted with caution.
Circulating irisin concentration correlated with cortical volumetric bone mineral density at the distal tibia (30% site) in individuals with SCI and controls
Outcome measures
| Measure |
Individuals With SCI
n=5 Participants
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 Participants
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Irisin-Cortical vBMD Correlation
|
0.833 Pearson Correlation Coefficient
|
0.026 Pearson Correlation Coefficient
|
PRIMARY outcome
Timeframe: baseline; at restPopulation: The correlations were analyzed separately for the Individuals with SCI group and the Controls group. Analyses were intended to determine if the correlation between the bone failure load and irisin was significant in each group, not to compare the correlations between groups. Given the sample size of the Controls group (n=3), the results should be interpreted with caution.
Circulating irisin concentration correlated with bone failure load at the distal tibia (4% site) in individuals with SCI and controls
Outcome measures
| Measure |
Individuals With SCI
n=5 Participants
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 Participants
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Irisin-Bone Failure Load Correlation
|
-0.432 Pearson Correlation Coefficient
|
-0.999 Pearson Correlation Coefficient
|
PRIMARY outcome
Timeframe: baseline; at restPopulation: The correlations were analyzed separately for the Individuals with SCI group and the Controls group. Analyses were intended to determine if the correlation between the bone failure load and irisin was significant in each group, not to compare the correlations between groups. Given the sample size of the Controls group (n=3), the results should be interpreted with caution.
Circulating irisin concentration correlated with bone failure load at the distal tibia (30% site) in individuals with SCI and controls
Outcome measures
| Measure |
Individuals With SCI
n=5 Participants
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 Participants
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Irisin-Bone Failure Load Correlation
|
-0.265 Pearson Correlation Coefficient
|
-0.986 Pearson Correlation Coefficient
|
PRIMARY outcome
Timeframe: baseline; at restPopulation: The correlations were analyzed separately for the Individuals with SCI group and the Controls group. Analyses were intended to determine if the correlation between the cortical porosity and irisin was significant in each group, not to compare the correlations between groups. Given the sample size of the Controls group (n=3), the results should be interpreted with caution.
Circulating irisin concentration correlated with cortical porosity at the distal tibia (30% site) in individuals with SCI and controls
Outcome measures
| Measure |
Individuals With SCI
n=5 Participants
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 Participants
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Irisin-Cortical Porosity Correlation
|
-0.660 Pearson Correlation Coefficient
|
0.859 Pearson Correlation Coefficient
|
PRIMARY outcome
Timeframe: Baseline; at restPopulation: For one individual with SCI, the microbiopsy sample was predominantly adipose tissue, thus insufficient tissue was available for analysis. Two individuals with SCI, decided not to participate in the muscle biopsy on the day of testing.
Vastus lateralis skeletal muscle FNDC5 gene expression relative to beta-2-microglobulin (ΔΔCt)
Outcome measures
| Measure |
Individuals With SCI
n=2 Participants
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 Participants
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
FNDC5 Gene Expression
|
0.0379 Fold Change
Standard Deviation 0.0510
|
0.3552 Fold Change
Standard Deviation 0.0624
|
PRIMARY outcome
Timeframe: Baseline (resting) to immediately post-acute exercise bout (~22 minutes later)Circulating irisin concentrations will be measured before and immediately following an arm ergometer high-intensity interval exercise bout
Outcome measures
| Measure |
Individuals With SCI
n=5 Participants
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 Participants
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Exercise Induced Change in Irisin Concentration
Baseline Concentrations
|
7.956 µg/ml
Standard Deviation 2.735
|
4.593 µg/ml
Standard Deviation 2.052
|
|
Exercise Induced Change in Irisin Concentration
Post-Exercise Concentrations
|
9.284 µg/ml
Standard Deviation 2.730
|
6.740 µg/ml
Standard Deviation 2.510
|
Adverse Events
Individuals With SCI
Controls (No SCI)
Serious adverse events
| Measure |
Individuals With SCI
n=8 participants at risk
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
Controls (No SCI)
n=3 participants at risk
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
12.5%
1/8 • From enrollment until visit 2 follow-up (approximately 48-72 hours later post-visit 2), an average of 15 days.
|
0.00%
0/3 • From enrollment until visit 2 follow-up (approximately 48-72 hours later post-visit 2), an average of 15 days.
|
|
Vascular disorders
High blood pressure
|
12.5%
1/8 • From enrollment until visit 2 follow-up (approximately 48-72 hours later post-visit 2), an average of 15 days.
|
0.00%
0/3 • From enrollment until visit 2 follow-up (approximately 48-72 hours later post-visit 2), an average of 15 days.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place