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Monoclonal Antibodies

Denosumab for Spinal Cord Injury

Phase 4
Waitlist Available
Led By Steven C Kirshblum, 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 prior to denosumab or placebo administration and 12 months after denosumab or placebo administration
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing if the drug denosumab can prevent bone loss in people who have had a recent spinal cord injury. The drug is already used for other bone loss conditions but is experimental for this purpose. It works by stopping the process that breaks down bones, helping to keep them strong.

Eligible Conditions
  • Bone Loss
  • Spinal Cord Injury

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA)
Secondary study objectives
X-Ray Computed Tomography

Side effects data

From 2015 Phase 3 trial • 90 Patients • NCT01377467
16%
Enteritis
16%
Tremor
14%
Lymphocele
11%
Transplant pyelonephritis
11%
CMV viremia
11%
Urinary tract infections
11%
Sore throat
9%
Thrombosis
9%
Diarrhea
9%
Hemorrhoids
9%
Exanthema
7%
Aphtous stomatitis
7%
Muscle pain
7%
Neck/back pain
7%
Headache
7%
Fever
7%
Rhinorrhea
7%
Oral candidiasis
5%
Urinary tract infection
5%
Hydronephrosis
5%
Surgical intervention
5%
Vomiting
2%
Flu-like disease
2%
Dyspnea
2%
Diabetes (post-transplant)
2%
Functional decline of transplant function
2%
Transplant ureter stenosis
2%
Peripheral arterial vascular disease
2%
Respiratory infection
2%
Sinusitis
2%
Transplant artery stenosis
2%
Uterus myomatosus
2%
Retinitis
2%
Wound dehiscence
2%
Bilateral nephrectomy of polycystic kidneys
2%
Hypocalcemia
2%
Alopecia
2%
Edema
2%
Nephrolithiasis
2%
Skin cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Denosumab

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Denosumab, AIS Grade D (ambulatory)Experimental Treatment1 Intervention
8 subjects with AIS grade D will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.
Group II: Denosumab, AIS Grade C (non-ambulatory)Experimental Treatment1 Intervention
8 subjects with AIS grade C will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.
Group III: Placebo, AIS Grade D (ambulatory)Placebo Group1 Intervention
8 subjects with AIS grade D will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.
Group IV: Placebo, AIS Grade C (non-ambulatory)Placebo Group1 Intervention
8 subjects with AIS grade C 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
2,875 Total Patients Enrolled
Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,160 Total Patients Enrolled
Steven C Kirshblum, M.D.Principal InvestigatorKessler Institute for Rehabilitation
2 Previous Clinical Trials
64 Total Patients Enrolled
William A Bauman, M.D.Principal InvestigatorJames J. Peters VA Medical Center
2 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03029442 — Phase 4
Spinal Cord Injury Research Study Groups: Placebo, AIS Grade D (ambulatory), Denosumab, AIS Grade C (non-ambulatory), Placebo, AIS Grade C (non-ambulatory), Denosumab, AIS Grade D (ambulatory)
Spinal Cord Injury Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT03029442 — Phase 4
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03029442 — Phase 4
~1 spots leftby Dec 2025
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