Last updated on March 2019

The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Spinal Cord Injury | Secondary Osteoporosis
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.