Prevention of Bone Loss After Acute SCI by Zoledronic Acid

Status Completed

Clinical Trial Summary

The overall objective of this study is to define an effective therapeutic approach, using currently available medication, to prevent or mitigate the loss of bone mass and bone strength that occurs after acute spinal cord injury.

Clinical Trial Description

This is a randomized, double-blind placebo-controlled study of zoledronic acid to evaluate its efficacy and safety over a 2 year period for the prevention of bone loss and maintenance of bone strength in individuals with recent onset SCI (see diagram below). Subjects will be randomized at the baseline visit to receive either zoledronic acid or placebo. At the end of the first year of the study, each treatment group will be re-randomized to either zoledronic acid or placebo to evaluate the durability of response to zoledronic acid and the utility of serum bone markers to guide therapeutic decision making. DXA imaging, CT imaging and bone markers will be obtained at baseline, 3 months, 6 months, 12 months, 18 months and 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02325414
Study type	Interventional
Source	Northwestern University
Contact
Status	Completed
Phase	Phase 2
Start date	February 2015
Completion date	August 25, 2020

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