Trial Outcomes & Findings for Prevention of Bone Loss After Acute SCI by Zoledronic Acid (NCT NCT02325414)

NCT ID: NCT02325414

Last Updated: 2025-12-02

Results Overview

Percent change of bone mass density (BMD) in the total hip (as measured by DXA)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

0-12 months

Results posted on

2025-12-02

Participant Flow

Patients with acute SCI were recruited from the Shirley Ryan AbilityLab, formerly known as the Rehabilitation Institute of Chicago. Recruitment took place between February 2015 and February 2018.

After meeting eligibility, participants were randomized in a blinded fashion and received study drug at the baseline visit.

Participant milestones

Participant milestones
Measure	Zoledronic Acid Intravenous infusion of zoledronic acid (zol) 5 mg at baseline.	Placebo Intravenous infusion of placebo (saline) at baseline.
Overall Study STARTED	30	30
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Zoledronic Acid Intravenous infusion of zoledronic acid (zol) 5 mg at baseline.	Placebo Intravenous infusion of placebo (saline) at baseline.
Overall Study Withdrawal by Subject	3	1
Overall Study Lost to Follow-up	5	5

Baseline Characteristics

Prevention of Bone Loss After Acute SCI by Zoledronic Acid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoledronic Acid n=30 Participants Intravenous infusion of zoledronic acid (Zol) 5 mg at baseline	Placebo n=30 Participants Intravenous infusion of placebo (saline) at baseline.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=9 Participants	28 Participants n=6 Participants	57 Participants n=9 Participants
Age, Categorical >=65 years	1 Participants n=9 Participants	2 Participants n=6 Participants	3 Participants n=9 Participants
Age, Continuous	37.3 years STANDARD_DEVIATION 15.9 • n=9 Participants	38.2 years STANDARD_DEVIATION 15.2 • n=6 Participants	37.8 years STANDARD_DEVIATION 15.4 • n=9 Participants
Sex: Female, Male Female	9 Participants n=9 Participants	3 Participants n=6 Participants	12 Participants n=9 Participants
Sex: Female, Male Male	21 Participants n=9 Participants	27 Participants n=6 Participants	48 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=9 Participants	7 Participants n=6 Participants	11 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=9 Participants	23 Participants n=6 Participants	49 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	2 Participants n=9 Participants	1 Participants n=6 Participants	3 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	8 Participants n=9 Participants	6 Participants n=6 Participants	14 Participants n=9 Participants
Race (NIH/OMB) White	20 Participants n=9 Participants	21 Participants n=6 Participants	41 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	2 Participants n=6 Participants	2 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Region of Enrollment United States	30 participants n=9 Participants	30 participants n=6 Participants	60 participants n=9 Participants
Time Since Injury (Days)	68.7 days STANDARD_DEVIATION 28.5 • n=9 Participants	62.7 days STANDARD_DEVIATION 23.2 • n=6 Participants	65.7 days STANDARD_DEVIATION 25.9 • n=9 Participants

PRIMARY outcome

Timeframe: 0-12 months

Percent change of bone mass density (BMD) in the total hip (as measured by DXA)

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=30 Participants Intravenous infusion of zoledronic acid (zol) 5 mg at baseline. Zoledronic acid: Intravenous infusion of zoledronic acid 5 mg.	Placebo n=30 Participants Intravenous infusion of placebo at baseline. Placebo: Placebo (saline) infusion to match zoledronic acid
Percent Change in Bone Mass Density (BMD) in the Hip	-2.21 percent change in bone mass density Interval -8.93 to 4.51	-12.82 percent change in bone mass density Interval -29.04 to 3.4

PRIMARY outcome

Timeframe: 0-12 months

Percent change of bone mass density (BMD) in the femoral neck (as measured by DXA)

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=30 Participants Intravenous infusion of zoledronic acid (zol) 5 mg at baseline. Zoledronic acid: Intravenous infusion of zoledronic acid 5 mg.	Placebo n=30 Participants Intravenous infusion of placebo at baseline. Placebo: Placebo (saline) infusion to match zoledronic acid
Percent Change of Bone Mass Density (BMD) in the Femoral Neck	-1.72 percent change in bone mass density Interval -7.05 to 3.59	-11.34 percent change in bone mass density Interval -22.29 to -0.39

SECONDARY outcome

Timeframe: 0-12 months

Percent change in the epiphyseal integral bone mass content (iBMC) of the femur, as collected by CT.

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=30 Participants Intravenous infusion of zoledronic acid (zol) 5 mg at baseline. Zoledronic acid: Intravenous infusion of zoledronic acid 5 mg.	Placebo n=30 Participants Intravenous infusion of placebo at baseline. Placebo: Placebo (saline) infusion to match zoledronic acid
Percent Change in the Epiphyseal Integral Bone Mass Content (iBMC) of the Femur	-9.6 percent change Interval -31.02 to 11.82	-22.90 percent change Interval -50.72 to 4.92

SECONDARY outcome

Timeframe: 0-12 months

Percent change in the metaphyseal integral bone mass content (iBMC) of the femur, as collected by CT

Outcome measures

Outcome measures
Measure	Zoledronic Acid n=30 Participants Intravenous infusion of zoledronic acid (zol) 5 mg at baseline. Zoledronic acid: Intravenous infusion of zoledronic acid 5 mg.	Placebo n=30 Participants Intravenous infusion of placebo at baseline. Placebo: Placebo (saline) infusion to match zoledronic acid
Percent Change in the Metaphyseal Integral Bone Mass Content (iBMC) of the Femur	-4.73 percent change Interval -13.83 to 4.37	-8.88 percent change Interval -19.12 to 1.36

Adverse Events

Zoledronic Acid

Serious events: 8 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Thomas Schnitzer

Northwestern University

Phone: 312-503-4043

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Zoledronic Acid n=30 participants at risk Intravenous infusion of the study drug zoledronic acid (Zol) 5 mg at baseline.	Placebo n=30 participants at risk Intravenous infusion of placebo at baseline. Placebo (Pla): saline
General disorders Acute Phase Response	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Psychiatric disorders Altered Mental Status	3.3% 1/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Nervous system disorders Autonomic Dysreflexia	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Infections and infestations C. difficile Infection	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Metabolism and nutrition disorders Dehydration	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Vascular disorders Thrombus	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Nervous system disorders Epilepsy	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Eye disorders Exophoria with Intermittent Exotropia	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Musculoskeletal and connective tissue disorders Gas (Incidental finding on X-ray)	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Blood and lymphatic system disorders Immune Thrombocytopenic Purpura	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Nervous system disorders Neuropathy, new or worsened	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Musculoskeletal and connective tissue disorders Osteomyelitis	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Musculoskeletal and connective tissue disorders Muscle pain (Back)	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Psychiatric disorders Panic Attack	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Skin and subcutaneous tissue disorders Pressure Ulcer	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Renal and urinary disorders Pyelonephritis	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Infections and infestations Septic Shock	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Injury, poisoning and procedural complications Traumatic Catheterization	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Renal and urinary disorders Urinary Tract Infection	10.0% 3/30 • Number of events 4 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	16.7% 5/30 • Number of events 5 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Psychiatric disorders Worsened Psychiatric Symptoms	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.

Measure	Zoledronic Acid n=30 participants at risk Intravenous infusion of the study drug zoledronic acid (Zol) 5 mg at baseline.	Placebo n=30 participants at risk Intravenous infusion of placebo at baseline. Placebo (Pla): saline
General disorders Acute Phase Response	66.7% 20/30 • Number of events 20 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	10.0% 3/30 • Number of events 3 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Nervous system disorders Autonomic Dysreflexia	10.0% 3/30 • Number of events 4 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Skin and subcutaneous tissue disorders Burn	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
General disorders Chills	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Gastrointestinal disorders Constipation	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
General disorders Cough	10.0% 3/30 • Number of events 3 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Injury, poisoning and procedural complications Fall	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
General disorders Fatigue/Weakness	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
General disorders Fever	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	10.0% 3/30 • Number of events 3 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Respiratory, thoracic and mediastinal disorders Flu	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Skin and subcutaneous tissue disorders Fungal Infection	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
General disorders Headache	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Musculoskeletal and connective tissue disorders Heterotopic Ossification, new or worsened	10.0% 3/30 • Number of events 3 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Vascular disorders Hypertension	10.0% 3/30 • Number of events 3 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Metabolism and nutrition disorders Hypocalcemia	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Musculoskeletal and connective tissue disorders Joint Pain	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	13.3% 4/30 • Number of events 4 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	3.3% 1/30 • Number of events 1 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Nervous system disorders Neuropathy, new or worsened	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 3 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Skin and subcutaneous tissue disorders Pressure Ulcer	10.0% 3/30 • Number of events 3 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	13.3% 4/30 • Number of events 4 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Nervous system disorders Spasticity, new or worsened	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	6.7% 2/30 • Number of events 4 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	26.7% 8/30 • Number of events 8 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Renal and urinary disorders Urinary Tract Infection	50.0% 15/30 • Number of events 26 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	33.3% 10/30 • Number of events 19 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.
Psychiatric disorders Worsened Depression Symptoms	6.7% 2/30 • Number of events 2 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.	0.00% 0/30 • Baseline - 12 month visit Adverse event collection began at the baseline visit, as soon as the participant received the first year study drug infusion. At each study visit, participants were asked about any changes to their health.