Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related event to a greater extent than that with bisphosphonate administration. In persons with complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL therapy appears to be more potent than bisphosphonates in animal models of bone loss due to immobilization, suggesting that treatment with denosumab may prove to be an efficacious therapy for persons with acute SCI to preserve bone mass and strength.
1 Primary · 1 Secondary · Reporting Duration: Baseline, 1, 3, 6, 12, and 18 months after Denosumab administration
24 Total Participants · 2 Treatment Groups
Primary Treatment: Denosumab · Has Placebo Group · Phase 4
Age 18 - 65 · All Participants · 3 Total Inclusion CriteriaMark “Yes” if the following statements are true for you: