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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-03-31

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.

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zoledronic acid

Single infusion of 5 mg zoledronic acid I.V.

Group Type ACTIVE_COMPARATOR

Zoledronic acid vs. placebo

Intervention Type DRUG

Single infusion of zoledronic acid or placebo

Placebo

Single infusion of 100 ml isotonic NaCl-solution I.V.

Group Type PLACEBO_COMPARATOR

Zoledronic acid vs. placebo

Intervention Type DRUG

Single infusion of zoledronic acid or placebo

Interventions

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Zoledronic acid vs. placebo

Single infusion of zoledronic acid or placebo

Intervention Type DRUG

Other Intervention Names

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Aclasta Zometa

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No