Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture
prevention and the associated morbidity of bed rest and further secondary complications.
Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more
effective than other agents in reducing bone mass resorption and leg fractures in
post-menopausal women, but has not been studied in patients with acute SCI. This will be a
randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after
SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus
placebo within 21 days of an SCI.
Phase:
Phase 3
Details
Lead Sponsor:
Thomas Jefferson University
Collaborators:
Department of Health and Human Services U.S. Department of Education