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Monoclonal Antibodies

Denosumab for Spinal Cord Injury

Phase 4
Waitlist Available
Led By William A Bauman, M.D.
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1, 3, 6, 12, and 18 months after denosumab administration
Awards & highlights

Study Summary

Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related event to a greater extent than that with bisphosphonate administration. In persons with complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL therapy appears to be more potent than bisphosphonates in animal models of bone loss due to immobilization, suggesting that treatment with denosumab may prove to be an efficacious therapy for persons with acute SCI to preserve bone mass and strength.

Eligible Conditions
  • Spinal Cord Injury
  • Osteoporosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12, and 18 months after denosumab administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12, and 18 months after denosumab administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone mineral density (BMD) of the distal femur
Secondary outcome measures
Bone microarchitecture of the distal femur and proximal tibia.

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256
44%
joint pain
22%
nausea
22%
propagation of fracture at biopsy site
11%
dizziness
11%
rhinorrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab Only
Teriparatide Only
Denosumab and Teriparatide

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DenosumabExperimental Treatment1 Intervention
A group of participants will be randomized to the experimental group and will have Denosumab (Prolia, 60 mg SC) administered at baseline, 6 and 12 months.
Group II: PlaceboPlacebo Group1 Intervention
A group of participants will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
FDA approved

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,876 Total Patients Enrolled
Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,141 Total Patients Enrolled
William A Bauman, M.D.Principal InvestigatorJames J. Peters VA Medical Center
2 Previous Clinical Trials
26 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Apr 2025