Overview

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

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Oulu
Collaborator:
Novartis Pharmaceuticals
Treatments:
Diphosphonates
Zoledronic Acid
Criteria
Inclusion Criteria:

- age over 18 years old

- low back pain for more than 3 months

- Modic type I or II change in lumbar magnetic resonance imaging

- Intensity of low back pain at least 6 on 10-cm VAS or Oswestry disability score at
least 30%

Exclusion Criteria:

- premenopausal female patients with possibility of pregnancy

- patients with calculated creatinine clearance of less than 40 ml/min

- patients with hypocalcemia

- patients with known hypersensitivity to zoledronic acid or other bisphosphonates or
ingredients of the infusional product

- patients with red flags symptoms

- patients with nerve root impingement

- patients with willingness for early retirement