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Monoclonal Antibodies

Romosozumab vs Denosumab for Osteoporosis After 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
Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C)
Males and females (premenopausal) between the ages of 18 and 55 years old
Must not have
Abnormalities of endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.
Current diagnosis of cancer or history of cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights

Summary

This trial is testing two ways to use medications that help keep bones strong in people with recent spinal cord injuries. One method uses a medication that helps build new bone for a period and then switches to another medication that prevents bone loss for another period. The other method uses only the medication that prevents bone loss for a longer period.

Who is the study for?
This trial is for men and premenopausal women aged 18-55 with a recent traumatic spinal cord injury (SCI) between C4-L2, who have not taken certain osteoporosis medications other than calcium and vitamin D. Participants must have a specific bone density level above the knee and cannot have conditions like chronic alcohol abuse, cancer history, severe chronic diseases, or be pregnant.
What is being tested?
The study tests if treating patients first with Romosozumab for 12 months followed by Denosumab for another year helps maintain bone mass at the knee better than just using Denosumab alone for two years in individuals with subacute SCI.
What are the potential side effects?
Romosozumab may cause muscle pain, headache, joint pain; it has potential risks of heart attack, stroke and cardiovascular death. Denosumab can lead to low blood calcium levels, skin rash or infection risk due to weakened immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a spinal cord injury between C4 and L2, with some level of paralysis.
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I am between 18 and 55 years old and if female, not past menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition affecting my hormone glands, like an overactive thyroid or Cushing's.
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I have been diagnosed with cancer or have a history of it.
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I had a major leg bone fracture in the last year.
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I have bone cancer.
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I have or had heart disease or a stroke.
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I have a history of bone disease like osteoporosis.
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I am a woman who has gone through menopause.
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I do not have severe chronic diseases like COPD, heart failure, or kidney failure.
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I had low testosterone levels before my spinal cord injury.
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I have been on more than 40 mg/day of corticosteroids for over a week, not for acute spinal cord injury.
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I have high levels of calcium in my blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

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) of the distal femur metaphysis

Side effects data

From 2016 Phase 3 trial • 245 Patients • NCT02186171
21%
Nasopharyngitis
9%
Hypertension
9%
Back pain
6%
Constipation
6%
Arthralgia
6%
Headache
5%
Procedural pain
2%
Muscle spasms
2%
Myalgia
1%
Escherichia sepsis
1%
Appendicitis perforated
1%
Thoracic vertebral fracture
1%
Cardio-respiratory arrest
1%
Coronary artery stenosis
1%
Subdural haematoma
1%
Basal cell carcinoma
1%
Death
1%
Implant site haematoma
1%
Cerebral ischaemia
1%
Depressed mood
1%
Non-cardiac chest pain
1%
Wolff-Parkinson-White syndrome
1%
Atrial flutter
1%
Device related infection
1%
Cerebrovascular accident
1%
Appendicitis
1%
Osteoarthritis
1%
Angina unstable
1%
Pneumonia
1%
Vascular encephalopathy
1%
Urinary tract infection
1%
Carotid artery stenosis
1%
Benign prostatic hyperplasia
1%
Anaemia postoperative
1%
Haemorrhagic stroke
1%
Cholecystitis
1%
Depression
1%
Oropharyngeal cancer
1%
Myocardial ischaemia
1%
Gastrooesophageal reflux disease
1%
Carotid arteriosclerosis
1%
Cardiac failure
1%
Laceration
1%
Rib fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Romosozumab 210 mg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24Experimental Treatment2 Interventions
Of the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive romosozumab (210mg SQ) once a month for 12 months. After 12 months the same twenty (20) individuals will receive denosumab (60mg SQ) at month 12 and 18.
Group II: Denosumab Baseline to Month 24Active Control1 Intervention
Of the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive denosumab (60 mg SQ) at baseline and 6, 12, and 18 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2013
Completed Phase 4
~12010
Romosozumab
2021
Completed Phase 4
~13930

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Romosozumab and Denosumab are two treatments being studied for their potential benefits in Spinal Cord Injury (SCI) patients. Romosozumab increases bone formation by inhibiting sclerostin, a protein that suppresses bone growth. Denosumab decreases bone resorption by inhibiting RANKL, a protein crucial for osteoclast activity, which breaks down bone tissue. These mechanisms are particularly important for SCI patients, who are prone to significant bone loss and fractures due to immobility. By promoting bone growth and reducing bone breakdown, these treatments aim to maintain bone density and reduce fracture risk, thereby improving the quality of life and clinical outcomes for SCI patients.

Find a Location

Who is running the clinical trial?

Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,125 Total Patients Enrolled
James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,860 Total Patients Enrolled
Steven C Kirshblum, M.D.Principal InvestigatorKessler Institute for Rehabilitation
2 Previous Clinical Trials
29 Total Patients Enrolled

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05101018 — Phase 4
Spinal Cord Injury Research Study Groups: Denosumab Baseline to Month 24, Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24
Spinal Cord Injury Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT05101018 — Phase 4
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05101018 — Phase 4
~11 spots leftby Nov 2025
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