The Efficacy of Denosumab to Prevent Bone Loss in Ambulatory and Non-ambulatory Motor-Incomplete Patients With Subacute Spinal Cord Injury

BAU-16-057

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.

2017-04-01

2021-12-31

2022-10-06

Terminated

Early phase I

5

Inclusion Criteria: 1. Motor incomplete SCI \[American Spinal Injury Association Impairment Scale (AIS) grades C and D\]; 2. Duration of injury \< 6-months; and 3. Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old. Exclusion Criteria: 1. Extensive life-threatening injuries in addition to SCI; 2. Acute fracture or extensive bone trauma; 3. History of prior bone disease (Paget's hyperparathyroidism, osteoporosis, etc.) 4. Post-menopausal women; 5. Men with known hypogonadism prior to SCI; 6. Anabolic or Steroid hormonal therapy; within the past year and longer than six months; 7. Hyperthyroidism; 8. Cushing's disease or syndrome; 9. Severe underlying chronic disease; 10. History of chronic alcohol abuse; 11. Diagnosis of Hypocalcemia; 12. Pregnancy; 13. Existing dental condition/dental infection; 14. Diagnosis of heterotopic ossification at the hip and/or knee region and receiving a bisphosphonates \[e.g. alendronate sodium (Fosamax) or etidronate disodium (Didronel)\] that will no longer make participants eligible to receive the study medication/placebo but are still eligible to complete follow-up outcome measures as described in the work schedule; 15. Current diagnosis of cancer or history of cancer; and 16. Any patient receiving moderate or high dose corticosteroids (\>40 mg/d prednisone or an equivalent dose of other corticosteroid) for longer than one week, not including drug administered in an attempt to preserve neurological function at the time of acute SCI.

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2024-03-15