The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury
Secondary Osteoporosis, Spinal Cord Injury
About this trial
This is an interventional treatment trial for Secondary Osteoporosis focused on measuring Spinal Cord Injury, Denosumab, Osteoporosis, Dual Energy X-ray Absorptiometry
Eligibility Criteria
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.)
- Post-menopausal women;
- Men with known hypogonadism prior to SCI;
- Anabolic or Steroid hormonal therapy; within the past year and longer than six months;
- Hyperthyroidism;
- Cushing's disease or syndrome;
- Severe underlying chronic disease;
- History of chronic alcohol abuse;
- Diagnosis of Hypocalcemia;
- Pregnancy;
- Existing dental condition/dental infection;
- 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;
- Current diagnosis of cancer or history of cancer; and
- 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.
Sites / Locations
- Kessler Institute for Rehabilitation
- James J. Peters VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Denosumab, AIS Grade C (non-ambulatory)
Placebo, AIS Grade C (non-ambulatory)
Denosumab, AIS Grade D (ambulatory)
Placebo, AIS Grade D (ambulatory)
8 subjects with AIS grade C will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.
8 subjects with AIS grade C will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.
8 subjects with AIS grade D will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.
8 subjects with AIS grade D will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.