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

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Zoledronic acid vs. placebo

• Registration Number: NCT01330238
• Lead Sponsor: University of Oulu

Brief 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2011-02-11
• Primary Completion: 2011-03
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Completion: 2012-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic acid	Zoledronic acid vs. placebo	Single infusion of 5 mg zoledronic acid I.V.
Placebo	Zoledronic acid vs. placebo	Single infusion of 100 ml isotonic NaCl-solution I.V.

Primary Outcome Measures

Name	Time	Method
Low back pain (VAS)	0, 1, 12 months

Secondary Outcome Measures

Name	Time	Method
Sick leaves	0, 12 months	Patient-reported
Health-related quality of life (RAND-36)	0, 1, 12 months
Radiologic phenotype	0, 12 months	Change in proportion and size of type I changes
Flexibility of the lumbar spine	0, 1, 12 months	Modified Schober measure
Disability (Oswestry)	0, 1, 12 months

Trial Locations

Locations (1)

Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu; 🇫🇮 Oulu, Finland