NCT01330238

The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)

Phase 2 Study of the Efficacy of Zoledronic Acid in Low Back Pain Related to Vertebral Endplate Signal Changes, the So-called Modic Changes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Modic changes are associated with low back pain (LBP) both in clinical and general population-based samples. Type I changes are regarded as more likely to be painful than type II changes. Several studies suggest that type I changes are inflammatory in nature.

Detailed description

So far, no treatment exists for LBP due to Modic changes. Bisphosphonates could be effective in this specific low back disorder through two mechanisms: 1) they could consolidate vertebral bodies thereby improving the tolerance for mechanical load and 2) they could diminish inflammation as observed recently in case of ibandronate in an experimental model.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Zoledronic acid vs. placebo	Single infusion of zoledronic acid or placebo

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-03-01
• Completion: 2012-03-01
• First posted: 2011-04-06
• Last updated: 2014-01-15

Locations

1 site across 1 country: Finland