---
title: The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)
nct_id: NCT01330238
overall_status: COMPLETED
phase: PHASE2
sponsor: University of Oulu
study_type: INTERVENTIONAL
primary_condition: Low Back Pain
countries: Finland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01330238.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01330238"
ct_last_update_post_date: 2014-01-15
last_seen_at: "2026-05-12T06:43:56.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)

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

**NCT ID:** [NCT01330238](https://clinicaltrials.gov/study/NCT01330238)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** University of Oulu
- **Collaborators:** Novartis Pharmaceuticals
- **Conditions:** Low Back Pain
- **Start Date:** 2008-12
- **Completion Date:** 2012-03
- **CT.gov Last Update:** 2014-01-15

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Zoledronic acid** (ACTIVE_COMPARATOR) — Single infusion of 5 mg zoledronic acid I.V.
- **Placebo** (PLACEBO_COMPARATOR) — Single infusion of 100 ml isotonic NaCl-solution I.V.

## Interventions

- **Zoledronic acid vs. placebo** (DRUG) — Single infusion of zoledronic acid or placebo

## Primary Outcomes

- **Low back pain (VAS)** _(time frame: 0, 1, 12 months)_

## Secondary Outcomes

- **Health-related quality of life (RAND-36)** _(time frame: 0, 1, 12 months)_
- **Flexibility of the lumbar spine** _(time frame: 0, 1, 12 months)_
- **Sick leaves** _(time frame: 0, 12 months)_
- **Radiologic phenotype** _(time frame: 0, 12 months)_
- **Disability (Oswestry)** _(time frame: 0, 1, 12 months)_

## Locations (1)

- Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu, Oulu, Finland

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.institute of clinical sciences, department of physical and rehabilitation medicine, university of oulu|oulu||finland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01330238.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01330238*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*