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Monoclonal Antibodies
Romosozumab + Denosumab for Spinal Cord Injury
Bronx, NY
Phase 4
Recruiting
Led By Christopher P Cardozo, MD
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 complete or incomplete SCI (every level of injury); International Standards for Neurological Classification of Spinal Cord Injury (ISNSCI) grade A-C (wheelchair dependent greater than 75% of the time)
Be older than 18 years old
Must not have
Bone cancer
Recent fracture or extensive bone trauma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will study whether a combination of two drugs can help maintain bone mass in people with chronic SCI.
See full description
Who is the study for?
This trial is for males aged 18-65 and premenopausal females aged 18-55 with chronic spinal cord injury (SCI) of more than 3 years, who are mostly wheelchair-dependent. Participants must have low bone density at the knee and agree to use effective contraception. Exclusions include weakened immune systems, heart disease history, recent heavy anti-inflammatory or bone density medication use, jawbone issues, abnormal calcium levels, cancer within the last five years, certain endocrine disorders, major fractures or surgeries in the past year.Check my eligibility
What is being tested?
The study tests if a year-long treatment with Romosozumab followed by Denosumab can maintain knee bone mass in people with long-term SCI. It compares these drugs against a placebo over a period of two years to see which is better at improving bone health.See study design
What are the potential side effects?
Potential side effects may include joint pain, headaches, injection site reactions like redness or swelling for both medications. Romosozumab might also cause cardiovascular issues such as heart attacks or strokes; Denosumab could lead to skin problems like eczema or rashes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a spinal cord injury and use a wheelchair most of the time.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have bone cancer.
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I have had a recent fracture or major injury to my bones.
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I had low testes function before my spinal cord injury.
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My immune system is currently weak or I have an infection.
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I have jaw bone issues or had major dental work in the last 6 months.
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I do not have severe chronic diseases like COPD, heart failure, or kidney failure.
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I had a major leg bone break in the last year.
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I have been diagnosed with cancer or had cancer in the last 5 years.
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I have been on high dose steroids (more than 40 mg/day) for over a week.
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I have a hormone-related condition like hyperthyroidism or Cushing's.
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I have or had heart disease or a stroke.
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I have been diagnosed with high calcium levels in my blood.
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I am a woman who has gone through menopause.
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I am taking medication for bone growth in the wrong places or for osteoporosis, excluding calcium and vitamin D.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bone mineral density (BMD)
Side effects data
From 2022 Phase 4 trial • 37 Patients • NCT0402625631%
nausea
15%
headache
15%
rhinorrhea
8%
phototoxic dermatitis
8%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teriparatide Only
Denosumab Only
Denosumab and Teriparatide
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Romosozumab groupExperimental Treatment2 Interventions
Romosozumab (evenity) administered monthly from baseline to month 11 followed by denosumab (prolia) at month 12 and 18
Group II: Control groupPlacebo Group2 Interventions
Placebo administered monthly from baseline to month 11 followed by denosumab (prolia) at month 12 and 18
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
FDA approved
Find a Location
Closest Location:Kessler Institute for Rehabilitation· West Orange, NJ· 464 miles
Who is running the clinical trial?
Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,126 Total Patients Enrolled
James J. Peters Veterans Affairs Medical CenterLead Sponsor
58 Previous Clinical Trials
2,824 Total Patients Enrolled
Christopher P Cardozo, MDPrincipal InvestigatorJames J Peters VA Medical Center
3 Previous Clinical Trials
25 Total Patients Enrolled
William A Bauman, MDPrincipal InvestigatorJames J Peters VA Medical Center
2 Previous Clinical Trials
151 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bone cancer.You have a history of drinking too much alcohol for a long time.I have been diagnosed with low blood calcium levels.The bone density in your lower leg is equal to or less than 1.0 grams per square centimeter.I have had a recent fracture or major injury to my bones.You have had a spinal cord injury for more than 3 years.I have been on medication to strengthen my bones for over 6 months after my spinal cord injury.I had low testes function before my spinal cord injury.I have abnormal bone growth in the lower part of my thigh bone.My immune system is currently weak or I have an infection.I am a man aged 18-65 or a premenopausal woman aged 18-55.I have jaw bone issues or had major dental work in the last 6 months.I do not have severe chronic diseases like COPD, heart failure, or kidney failure.I have a spinal cord injury and use a wheelchair most of the time.I had a major leg bone break in the last year.I have been diagnosed with cancer or had cancer in the last 5 years.I have been on high dose steroids (more than 40 mg/day) for over a week.I have been on glucocorticoids for more than three months in the past year.You are not expected to live for more than 5 years.I have a hormone-related condition like hyperthyroidism or Cushing's.I have or had heart disease or a stroke.I have been diagnosed with high calcium levels in my blood.You have had a bad reaction to any part of Prolia or Evenity in the past.I am a woman who has gone through menopause.I am taking medication for bone growth in the wrong places or for osteoporosis, excluding calcium and vitamin D.I plan to have a dental surgery within the next two years.
Research Study Groups:
This trial has the following groups:- Group 1: Romosozumab group
- Group 2: Control group
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.