Accession Number:

AD1033786

Title:

Prevention of Bone Loss after Acute SCI by Zoledronic Acid: Durability, Effect on Bone Strength, and Use of Biomarkers to Guide Therapy

Descriptive Note:

Technical Report,29 Sep 2015,28 Sep 2016

Corporate Author:

Northwestern University Evanston United States

Personal Author(s):

Report Date:

2016-10-01

Pagination or Media Count:

6.0

Abstract:

Rapid bone loss is a universal accompaniment of acute spinal cord injury SCI and leads to severe loss of bone mass and bone strength with a marked increased risk of fracture. This 24 month double-blind, randomized, placebo-controlled study evaluates in 60 participants the efficacy bone mass and bone strengthand safety of zoledronic acid administered early after acute SCI to prevent bone loss, the duration of its effects and the value of using biomarkers to guide therapy. Data collection bone imaging and biomarkers occurs at baseline and after 3, 6 and 12 months during the first year participants are re-randomized after 12 months with subsequent data collection at 18 and 24 months. Currently, all regulatory requirements for the study have been completed. Thirty 30 participants have been randomized and treated. No unexpected safety events have occurred. Data collection is on-going and additional patients are being screened for study entry.

Subject Categories:

  • Medicine and Medical Research
  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE