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Romosozumab + Denosumab for Spinal Cord Injury
Study Summary
This trial will study whether a combination of two drugs can help maintain bone mass in people with chronic SCI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 37 Patients • NCT04026256Trial Design
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- 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.
- Group 1: Control group
- Group 2: Romosozumab group
- 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.
- 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
Is there a body of evidence that has been generated around Romoszumab?
"Romoszumab was first researched in 2016 at Xavier Nogues, with 18426 studies eventually completed. Currently, there are 54 ongoing clinical trials of this medication primarily being conducted out of Bronx, New york."
Is the age criterion for this clinical trial above or below 35 years?
"This clinical trial requires that participants are between 18 and 50 years of age."
Are there still available slots for participants in this research endeavor?
"Indeed, the clinical trial is open for recruitment with data available on clinicaltrials.gov verifying this fact. This study was initially made public on March 1st 2021 and its information has been recently refreshed as of April 1st 2022. 39 volunteers are needed to be sourced from 2 distinct healthcare facilities."
Who are the ideal candidates to take part in this clinical research?
"This clinical trial is open to both male and female individuals of premenopausal age (18-50) who have suffered a spinal cord injury, with motor complete or incomplete SCI C4 and below. These participants must also meet the criteria that their duration of SCI is between 3-15 years; bone density at distal femur equal to 0.6 g/cm2 - 1.0 g/cm2; and agreement for highly effective contraception among women of childbearing potential. The maximum participant count stands at 39 people total."
What are the inherent risks associated with Romoszumab treatment?
"Our evaluative team at Power considers Romoszumab to be a safe treatment and have assigned it a score of 3. This is due to the fact that this drug has passed Phase 4 trials, indicating its approval for use in clinical settings."
What is the projected participant enrollment for this experiment?
"Affirmative. Clinicaltrials.gov reflects that this clinical study, which first appeared on March 1st 2021, is still recruiting individuals for participation. 39 participants are being sought after at two separate sites."
What primary conditions is Romoszumab prescribed to manage?
"Romoszumab is commonly applied to treat skeletally mature individuals and can prove beneficial in addressing issues like malignant neoplasms, osteoporosis, and hormone imbalances."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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