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