The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury (NCT03029442) | Clinical Trial Compass
TerminatedPhase 4
The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury
Stopped: Study ended early due to COVID-19
United States5 participantsStarted 2017-04-01
Plain-language summary
The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Motor incomplete SCI \[American Spinal Injury Association Impairment Scale (AIS) grades C and D\];
. Duration of injury \< 6-months; and
. Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old.
Exclusion criteria
. Extensive life-threatening injuries in addition to SCI;
. Acute fracture or extensive bone trauma;
. History of prior bone disease (Paget's hyperparathyroidism, osteoporosis, etc.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA)
Timeframe: Prior to denosumab or placebo administration and 18 months after denosumab or placebo administration
Trial details
NCT IDNCT03029442
SponsorJames J. Peters Veterans Affairs Medical Center