NCT01983475

Denosumab Administration After Spinal Cord Injury

The Efficacy of Denosumab to Reduce Osteoporosis After Spinal Cord Injury

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: James J. Peters Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective of this study is to test the efficacy of a potent anti-resorptive agent, denosumab \[receptor activator of nuclear factor-κB ligand (RANKL) antibody; Amgen Inc.\] to preserve bone mass at the hip and knee and trabecular connectivity at the knee after acute SCI. Setting: patient enrollment, study drug administration and DXA scanning will be completed at the Kessler Institute for Rehabilitation (KIR) and pQCT measurements will be performed at Columbia University. A Randomized, double-blind, placebo-controlled parallel group trial. Twenty-four subjects with acute, motor complete SCI (≤12 weeks) who have been admitted to the Kessler Institute for Rehabilitation (KIR) will be recruited for participation. The age of study participation will be males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old. Primary outcome measure will be BMD as measured by DXA and microarchitecture as measured by pQCT at the hip and knee.

Conditions

• Osteoporosis
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Denosumab	In clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates.39,40 The rate of bone loss in the lower extremity at sites of interest in patients with acute SCI has been reported to be several-fold greater than the rate of bone loss in postmenopausal women not prescribed antiresorptive medications, which is about 3-5% per year.11,50,51 The dose of denosumab chosen for our protocol in patients after acute SCI will be the same dose that has been shown to be efficacious to treat postmenopausal osteoporosis (60 mg SQ q 6 months).
DRUG	Placebo (identical Denosumab volume of normal saline)	The placebo group will receive the identical volume of normal saline at parallel time points.

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2013-11-14
• Last updated: 2019-03-08

Locations

2 sites across 1 country: United States