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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01330238

Enrollment

Registered

2011-04-06

Start date

2008-12-31

Completion date

2012-03-31

Last updated

2014-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low back pain, Modic changes, Vertebral endplate signal changes, Efficacy, Zoledronic acid, Bisphosphonates, RCT

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.

Interventions

DRUGZoledronic acid vs. placebo

Single infusion of zoledronic acid or placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Low back pain (VAS)	0, 1, 12 months

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026