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Sclerostin Antagonist
Romosozumab for Osteoporosis in Chronic Spinal Cord Injury
Phase 2
Recruiting
Led By William A. Bauman, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0), month 1, month 3, month 6, month 12, month 18, month 24
Awards & highlights
Study Summary
This trial is testing a new treatment for osteoporosis in people with chronic spinal cord injury. The treatment is Romosozumab, a sclerostin antagonist, which has potential to increase bone formation (anabolic) and decrease bone resorption (anti-catabolic) in persons with chronic SCI.
Who is the study for?
This trial is for men and women aged 18-55 with chronic spinal cord injury (SCI) who have low bone density at the distal femur. Participants must be more than three years post-injury, with motor-complete or incomplete SCI below C4. Exclusions include severe chronic diseases, recent high-dose steroid use, cancer history, certain endocrine disorders, pregnancy, alcohol abuse, and prior treatments for bone loss.Check my eligibility
What is being tested?
The study tests Romosozumab's ability to increase bone density in people with chronic SCI followed by Denosumab to maintain or boost this effect. It's a two-group trial where one group gets Romosozumab then Denosumab while the control group receives a placebo then Denosumab over a total of 24 months.See study design
What are the potential side effects?
Romosozumab may cause muscle pain, headache, joint pain; it has potential risks like heart attack and stroke. Denosumab can lead to infections in skin or ear canals, osteonecrosis of the jaw (bone damage), hypocalcemia (low calcium levels), and back pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (0), month 1, month 3, month 6, month 12, month 18, month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0), month 1, month 3, month 6, month 12, month 18, month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in vBMD at the Distal Femur, measured by pQCT after 12 months of romosozumab treatment
Change in vBMD at the distal femur after an additional 12 months of denosumab treatment
Other outcome measures
Additional variables by DXA - aBMD Distal Femur and Proximal Tibia (i.e. knee)
Additional variables by DXA - aBMD Hip
Additional variables by pQCT - Distal Tibia Microarchitecture
+9 moreSide 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%
Myalgia
2%
Muscle spasms
1%
Oropharyngeal cancer
1%
Carotid artery stenosis
1%
Cerebral ischaemia
1%
Anaemia postoperative
1%
Depressed mood
1%
Thoracic vertebral fracture
1%
Urinary tract infection
1%
Subdural haematoma
1%
Rib fracture
1%
Vascular encephalopathy
1%
Laceration
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
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Romosozumab Treatment (baseline to month 11)Experimental Treatment1 Intervention
Of the thirty-nine (39) individuals with chronic spinal cord injury (SCI) enrolled in this study, twenty-six (26) participants will be randomly selected to received romosozumab (210mg SQ) once a month for 12 months.
Group II: Denosumab (month 12 to month 24)Active Control1 Intervention
Both groups (treatment and placebo) will receive denosumab (60mg SQ) at months 12 and 18 for maintenance of or to further increase bone mineral density (BMD) at regions of interest (ROI).
Group III: Placebo (baseline to month 12)Placebo Group1 Intervention
Of the thirty-nine (39) individuals with chronic SCI enrolled in this study, thirteen (13) participants will be randomly selected to received placebo injections (NS SQ) once a month for 12 months. They will follow study procedures identical to those performed by individuals in the treatment (romosozumab) group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romosozumab
2021
Completed Phase 4
~13910
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,567 Total Patients Enrolled
Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,129 Total Patients Enrolled
William A. Bauman, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 55 years old and can have children.I have been on high-dose steroids for more than a week in the past year, not for spinal cord injury.Your bone density at the lower part of your thigh is less than 1.0 grams per square centimeter.I do not have severe chronic diseases like COPD, heart failure, or kidney failure.I had low testosterone levels before my spinal cord injury.I have bone growth in my knee area but not on other medications that are not allowed.I have been on anabolic therapy for more than 6 months after my spinal cord injury.I have a hormone-related condition like hyperthyroidism or Cushing's.You have low levels of calcium in your blood.I have been diagnosed with cancer or have a history of it.I have been diagnosed with osteosarcoma.I have had heart disease or a stroke in the last year.Your injury has lasted for more than 3 years.I had a major leg bone break in the last year.You have a history of drinking alcohol excessively over a long period of time.I am taking medication for bone health, not including calcium or vitamin D.I am receiving electrical stimulation therapy on my legs.You have a spinal cord injury that affects your ability to move and feel below a certain level in your neck.You are not expected to live for more than 5 years.I have a history of bone disease like Paget's or osteoporosis.I am a woman who has gone through menopause.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo (baseline to month 12)
- Group 2: Denosumab (month 12 to month 24)
- Group 3: Romosozumab Treatment (baseline to month 11)
Awards:
This trial has 0 awards, including: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.
Has the FDA cleared Romosozumab for public use?
"Romosozumab falls into the category of a Phase 2 drug, meaning that while there is some evidence of safety, there is no data yet to support efficacy."
Answered by AI
For what purpose is Romosozumab most frequently prescribed?
"Romosozumab is frequently used to treat skeletally mature patients. However, it can also help those struggling with androgens, malignant neoplasms, and osteoporosis."
Answered by AI
How many research subjects are involved in this investigation?
"Yes, this study is still looking for participants. According to the information available on clinicaltrials.gov, the trial was first posted on October 28th 2020 and was edited most recently on April 5th 2022. There are currently 39 patients needed from 2 locations."
Answered by AI
Who would be able to join this medical study?
"Osteoporosis caused by sciatica and patients aged 18 to 50 are ideal candidates for this study. Currently, the team is looking to recruit 39 individuals."
Answered by AI
Are there any unfilled appointments for this research project?
"Yes, this trial is still open and recruiting patients. According to the clinicaltrials.gov website, the study was first advertised on October 28th 2020 and was updated as recently as April 5th, 2022."
Answered by AI
Are people of legal age able to participate in this research?
"This particular study is only enrolling patients aged between 18-50. There are 44 clinical trials for individuals under the age of eighteen and 370 for those over sixty-five years old."
Answered by AI
Are there any other research projects that have utilized Romosozumab?
"Romosozumab's first clinical trial was at Hirslanden Klinik Aarau in 2014. So far, a total of 18387 studies have completed. Right now, there are 56 active trials, with several happening in Bronx, New york."
Answered by AI
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