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

University of Oulu

Status and phase

Completed

Phase 2

Conditions

Low Back Pain

Treatments

Drug: Zoledronic acid vs. placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01330238

EudraCT 2008-005351-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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