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 range18 Years â 65 Years
SexALL
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
â. Motor incomplete SCI \[American Spinal Injury Association Impairment Scale (AIS) grades C and D\];
â. Duration of injury \< 6-months; and
â. Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old.
Exclusion criteria
â. Extensive life-threatening injuries in addition to SCI;
â. Acute fracture or extensive bone trauma;
â. History of prior bone disease (Paget's hyperparathyroidism, osteoporosis, etc.)
â. Post-menopausal women;
â. Men with known hypogonadism prior to SCI;
â. Anabolic or Steroid hormonal therapy; within the past year and longer than six months;
â. Hyperthyroidism;
â
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