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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
Motor incomplete SCI (AIS grades C and D)
Duration of injury < 6-months
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

Study Summary

This trial is testing whether Denosumab can help prevent bone loss in legs due to SCI. The study will last for 12 months, with 6 visits ranging from 1-4.5 hours. The trial is double-blinded, meaning participants will be randomly assigned to Denosumab or placebo injections, not knowing which they are receiving.

Eligible Conditions
  • Osteoporosis
  • Spinal Cord Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have partial paralysis from a spinal cord injury.
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Your injury happened less than 6 months ago.
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Men who are between 18 and 65 years old.
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Women aged 18 to 50 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA)
Secondary outcome measures
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
55 Previous Clinical Trials
2,883 Total Patients Enrolled
4 Trials studying Osteoporosis
124 Patients Enrolled for Osteoporosis
Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,163 Total Patients Enrolled
4 Trials studying Osteoporosis
124 Patients Enrolled for Osteoporosis
Steven C Kirshblum, M.D.Principal InvestigatorKessler Institute for Rehabilitation
2 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Osteoporosis
64 Patients Enrolled for Osteoporosis

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03029442 — Phase 4
Osteoporosis Research Study Groups: Denosumab, AIS Grade C (non-ambulatory), Denosumab, AIS Grade D (ambulatory), Placebo, AIS Grade D (ambulatory), Placebo, AIS Grade C (non-ambulatory)
Osteoporosis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Denosumab (Prolia) for medical use?

"Data from clinical trials marking this medication's approval place the safety of Denosumab (Prolia) at a 3 on our team's rating scale."

Answered by AI

What are the eligibility criteria for participating in this experiment?

"This clinical trial requires 32 individuals suffering from SCI between 18 and 65 years old. Notably, participants must have an AIS of C or D, their injury should be less than 6 months old, males must be aged 18-65 while females need to be under 50 years old."

Answered by AI

Are there any other research projects that have explored the effects of Denosumab (Prolia)?

"Denosumab (Prolia) was initially trialled in 2016 at Xavier Nogues. To date, the drug has been studied 115 times, with 47 active trials occurring primarily out of Bronx, New york."

Answered by AI

How many participants are anticipated for this medical experiment?

"Affirmative. Information from clinicaltrials.gov specifies that this research endeavour is currently enrolling participants; it was posted on April 1st 2017, and has most recently been updated on March 6th 2019. A total of 32 patients need to be enrolled at 2 distinct medical centres."

Answered by AI

Are there any vacancies available to participate in this clinical trial?

"Per the details found on clinicaltrials.gov, this research trial is open for enrollment and was initially launched on April 1st 2017 before being updated lastly on March 6th 2019."

Answered by AI

Is the participant demographic of this trial limited to adults aged 25 and over?

"This trial is seeking participants aged 18-65. Those younger than the age of consent can look into the 157 trials catered to their demographic, while those over 65 are encouraged to review the 887 clinical studies available for them."

Answered by AI

What therapeutic conditions is Denosumab (Prolia) employed in?

"The drug denosumab (Prolia) is frequently utilized to treat bone-related issues, as well as skeletally mature individuals and certain malignant neoplasms."

Answered by AI
~4 spots leftby Feb 2025