Zoledronic Acid Administration in Acute Spinal Cord Injury
Condition: Disuse Osteoporosis
MeSH terms: Osteoporosis; Spinal Cord Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on
      preservation of regional and total skeletal mass (DXA).

      Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI,
      as evidenced by serial densitometry determinations (DXA).
    

Detailed description: 
      Immobilization is associated with disuse osteoporosis. Spinal cord injury (SCI) produces a
      syndrome of acute skeletal immobilization with immediate and irreversible unloading of the
      involved skeletal regions resulting in accelerated bone loss. In addition to rapid bone loss,
      there are also the complications of hypercalciuria, hypercalcemia, nephrolithiasis, and renal
      insufficiency. In some reports, as much as 50% of regional bone mass has been lost within the
      first year after paralysis. A depletion of regional bone of such magnitude greatly increases
      the risk of fractures, with associated morbidity and increased cost of care. Often, these
      fractures occur with minimal or non-obvious trauma and may pass undiagnosed for varying
      lengths of time due to the absence of pain sensation. The acute complications of fracture may
      include hemorrhage, deep venous thrombosis, and autonomic dysreflexia. Long-term
      complications include functional deformity, non-union, infection, heterotopic calcification,
      and significantly longer healing time. The sociology-economic consequences include a minimum
      of 1 to 2 weeks of hospitalization and the potential need for an increased level of attendant
      care. This study will address the efficacy of a bisphosphonate, zoledronic acid (Reclast: 5
      mg; Novartis Pharmaceuticals Inc., East Hanover, NJ), in the prevention of the bone loss
      associated with acute SCI.

      Prevention of regional osteoporosis in persons with SCI would reduce the morbidity associated
      with fractures, a known secondary complication of immobilization. Thus, the quality of life
      would be improved in terms of employment responsibilities (reduction in days absent from
      employment and income lost) and personal activities (recreational endeavors, independence,
      and ease in which one performs activities of daily living). Individuals with SCI may then
      engage more securely in activities without fear of fracture, a tremendous psychological
      benefit.
    

Intervention name(s): Zoledronic acid
Intervention type(s): Drug
Intervention description(s): At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
Other intervention name(s): Zometa; Reclast
Intervention MeSH terms: Zoledronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Disuse Osteoporosis; Zoledronic acid; Bisphosphonates; Dual Energy X-ray Absorptiometry