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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
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to denosumab or placebo administration and 12 months after denosumab or placebo administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to denosumab or placebo administration and 12 months after denosumab or placebo administration
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 • NCT0137746716%
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
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
2,895 Total Patients Enrolled
4 Trials studying Osteoporosis
124 Patients Enrolled for Osteoporosis
Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,160 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious long-term health condition.Women who have already gone through menopause.You are taking a high amount of corticosteroids for more than a week.You have partial paralysis from a spinal cord injury.Women aged 18 to 50 years old.You have very serious injuries in addition to spinal cord injury that could be life-threatening.You have recently broken a bone or have had severe bone injury.You have had bone diseases like Paget's, hyperparathyroidism, or osteoporosis in the past.You have a history of drinking alcohol excessively for a long time.You have a dental problem or infection.Your injury happened less than 6 months ago.Men who are between 18 and 65 years old.Men with a known condition of low testosterone levels before spinal cord injury.You have been diagnosed with low levels of calcium in your blood.You have been diagnosed with abnormal bone growth in the hip or knee area and are taking certain medications for it.You currently have cancer or have had cancer in the past.You have taken anabolic or steroid hormonal therapy in the past year for more than six months.You have overactive thyroid.You have Cushing's disease or syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo, AIS Grade D (ambulatory)
- Group 2: Denosumab, AIS Grade C (non-ambulatory)
- Group 3: Placebo, AIS Grade C (non-ambulatory)
- Group 4: Denosumab, AIS Grade D (ambulatory)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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