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

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.

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.

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