Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
Study Summary
This trial will compare two treatments for bone loss in people with recent spinal cord injury.
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.Check my eligibility
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.See study design
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 belowSelect...
I have a spinal cord injury between C4 and L2, with some level of paralysis.
Select...
I am between 18 and 55 years old and if female, not past menopause.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone mineral density (BMD) of the distal femur metaphysis
Side effects data
From 2016 Phase 3 trial • 245 Patients • NCT0218617121%
Nasopharyngitis
9%
Back pain
9%
Hypertension
6%
Arthralgia
6%
Constipation
6%
Headache
5%
Procedural pain
2%
Muscle spasms
2%
Myalgia
1%
Cerebral ischaemia
1%
Thoracic vertebral fracture
1%
Urinary tract infection
1%
Subdural haematoma
1%
Laceration
1%
Rib fracture
1%
Anaemia postoperative
1%
Oropharyngeal cancer
1%
Carotid artery stenosis
1%
Vascular encephalopathy
1%
Depressed mood
1%
Atrial flutter
1%
Death
1%
Device related infection
1%
Escherichia sepsis
1%
Coronary artery stenosis
1%
Cardio-respiratory arrest
1%
Carotid arteriosclerosis
1%
Cerebrovascular accident
1%
Angina unstable
1%
Implant site haematoma
1%
Non-cardiac chest pain
1%
Appendicitis perforated
1%
Cardiac failure
1%
Cholecystitis
1%
Appendicitis
1%
Pneumonia
1%
Haemorrhagic stroke
1%
Depression
1%
Benign prostatic hyperplasia
1%
Myocardial ischaemia
1%
Wolff-Parkinson-White syndrome
1%
Gastrooesophageal reflux disease
1%
Osteoarthritis
1%
Basal cell carcinoma
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
2017
Completed Phase 4
~12500
Romosozumab
2021
Completed Phase 4
~13910
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition affecting my hormone glands, like an overactive thyroid or Cushing's.Your bone density near your knee needs to be within a safe range, as determined by the study staff.I have bone growth outside of the skeleton in the knee end of my thigh bone.I have been diagnosed with cancer or have a history of it.I had a major leg bone fracture in the last year.You have had a spinal cord injury for less than 6 months.I have been on medication to increase bone density for more than 6 months after a spinal cord injury.I have bone cancer.I have or had heart disease or a stroke.I have a history of bone disease like osteoporosis.I am a woman who has gone through menopause.I have a spinal cord injury between C4 and L2, with some level of paralysis.You are not expected to live for more than 5 years.You have a history of drinking too much alcohol for a long time.I do not have severe chronic diseases like COPD, heart failure, or kidney failure.I am taking medication for bone growth or osteoporosis, not including calcium and vitamin D.I had low testosterone levels before my spinal cord injury.I have been on more than 40 mg/day of corticosteroids for over a week, not for acute spinal cord injury.I am between 18 and 55 years old and if female, not past menopause.I have high levels of calcium in my blood.
Research Study Groups:
This trial has the following groups:- Group 1: Denosumab Baseline to Month 24
- Group 2: Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which patients does Romosozumab help the most?
"Romosozumab is a common treatment for skeletally mature patients. However, it can also be used to manage androgens, malignant neoplasms, and osteoporosis."
Answered by AI
How many test subjects are needed for this clinical study?
"The information available on clinicaltrials.gov supports that this trial is looking for participants. This study was posted on November 1st, 2021 and has since been updated December 17th, 2021. At the moment, they are recruiting 40 patients from 2 different locations."
Answered by AI
Does this research include elderly participants over the age of eighty-five?
"The age criteria to participate in this clinical trial are that patients must be over 18 but under 50 years old."
Answered by AI
Are we still receiving applications for this research project?
"Yes, as can be seen on clinicaltrials.gov, this particular medical trial is still recruiting patients. This specific study was originally posted on November 1st 2021 and was updated December 17th 2021."
Answered by AI
Are there any short-term or long-term side effects of Romosozumab?
"Romosozumab has already been approved, as this is a Phase 4 trial. Therefore, it receives a score of 3 for safety."
Answered by AI
Can you provide more context on Romosozumab's clinical applications?
"Romosozumab is being trialled in 589 locations, with 56 of those trials currently active. Of the active studies, 15 are in Phase 3. Many of the trials for Romosozumab are based in Izmir and Madrid."
Answered by AI
What are the requirements for patients who want to join this clinical study?
"This clinical trial is testing a new osteoporosis medication and requires 40 participants that are currently suffering from the condition. These individuals must also be between 18-50 years old and have had their spinal cord injury (SCI) for less than 6 months."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger