Trial intelligence / Profile preview

Zoledronic acid for Modic change-related low back pain

NCT01330238Phase 2

Key facts

Status: Completed
Start: Dec 2008
Primary completion: Mar 2011
Countries: 1
Sponsor: University of Oulu
Modality: Small Molecules

Drugs: zoledronic acid
Conditions: low back pain (LBP)

Overview

Phase 2, randomised, double-blind trial in low back pain (LBP) comparing Zoledronic acid with Placebo (2 arms). Primary endpoint: Low back pain intensity (VAS) at 12 months. Started Dec 2008; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Zoledronic acid
Single infusion of 5 mg zoledronic acid I.V.
Placebo
Single infusion of 100 ml isotonic NaCl-solution I.V.

Who it enrols

Adult patients with low back pain for more than 3 months, Modic type I or II changes on MRI, and pain intensity of at least 6/10 on VAS or Oswestry score of at least 30%.

Endpoints

Primary

Low back pain intensity (VAS)12 months

Secondary

Health-related quality of life (RAND-36)12 months
Flexibility of the lumbar spine12 months
Sick leaves12 months
Radiologic phenotype12 months
Disability (Oswestry)12 months

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