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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2 Study of the Efficacy of Zoledronic Acid in Low Back Pain Related to Vertebral Endplate Signal Changes, the So-called Modic Changes

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Zoledronic acid vs. placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zoledronic acid<br>Single infusion of 5 mg zoledronic acid I.V. | Drug: Zoledronic acid vs. placebo<br>* Single infusion of zoledronic acid or placebo<br>* Other names: Zometa;|
| Placebo Comparator: Placebo<br>Single infusion of 100 ml isotonic NaCl-solution I.V. | Drug: Zoledronic acid vs. placebo<br>* Single infusion of zoledronic acid or placebo<br>* Other names: Zometa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain (VAS) |  | 0, 1, 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Modic changes, Vertebral endplate signal changes, Efficacy, Zoledronic acid, Bisphosphonates, RCT