NCT03029442

The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury

The Efficacy of Denosumab to Prevent Bone Loss in Ambulatory and Non-ambulatory Motor-Incomplete Patients With Subacute Spinal Cord Injury

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: James J. Peters Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.

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 subacute motor-incomplete SCI \[American Spinal Injury Association (AIS) neurological classification scale C and D\] at the James J. Peters VA Medical Center (JJPVAMC) and Kessler Institute for Rehabilitation (KIR). A randomized, double-blind, placebo-controlled, parallel group trial will be performed in thirty-two subjects with acute, motor-incomplete SCI (≤6 months) who have been admitted to JJPVAMC or the KIR. Denosumab (60 mg SC) will be administered at baseline, 6, and 12 months; the placebo group will receive normal saline subcutaneously. Denosumab will be administered as soon as possible, but up to 24 weeks, after SCI. The last dose of denosumab and placebo will be administered at 6 months, with the anticipated effect of the drug to persist and inhibit bone resorption at least until the 12 month time point.

Conditions

• Secondary Osteoporosis
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Denosumab (Prolia)	In clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates. 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).
OTHER	Placebo (normal saline)	Identical Denosumab volume of normal saline

Timeline

• Start date: 2017-04-01
• Primary completion: 2021-12-31
• Completion: 2022-10-06
• First posted: 2017-01-24
• Last updated: 2024-03-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study