Disuse Osteoporosis Clinical Trial
Official title:
The Efficacy of Zoledronic Acid in the Prevention of Bone Loss in Acute Spinal Cord Injury
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).
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02309983 -
Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes
|
N/A |