Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

Phase 2 Terminated 17 enrolled Thomas J. Schnitzer Novartis · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.

Timeline

Start: 2010-03
Primary completion: 2015-12
Completion: 2016-01

Outcome

Met primary endpoint

Stopped (Enrollment): “difficulty in enrollment”

paper The group treated with zoledronic acid had a smaller decrease in BMD at 6 months at the total hip than the placebo group PMID 26828618 ↗

registry analysis (superiority test); Zoledronic Acid vs Placebo; p = .03; t-test, 2 sided NCT00844480 ↗

Publications

Results Schnitzer TJ, Kim K, Marks J, Yeasted R, Simonian N, Chen D. Zoledronic Acid Treatment After Acute Spinal Cord Injury: Results of a Randomized, Placebo-Controlled Pilot Trial. PM R. 2016 Sep;8(9):833-43. doi: 10.1016/j.pmrj.2016.01.012. Epub 2016 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zoledronic acid	Other / unclassified	5 mg	Intravenous