The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury

This is an interventional treatment trial for Secondary Osteoporosis focused on measuring Spinal Cord Injury, Denosumab, Osteoporosis, Dual Energy X-ray Absorptiometry Read More

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.