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OpenTrials
Completed

NCT Number: NCT01330238

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

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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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Oulu, 90014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid vs. placebo

Drug

Single infusion of zoledronic acid or placebo

Other names: Aclasta, Zometa

Primary outcomes

  1. Low back pain (VAS)

    Time frame: 0, 1, 12 months

Secondary outcomes

  1. Health-related quality of life (RAND-36)

    Time frame: 0, 1, 12 months

  2. Flexibility of the lumbar spine

    Time frame: 0, 1, 12 months

    Modified Schober measure

  3. Sick leaves

    Time frame: 0, 12 months

    Patient-reported

  4. Radiologic phenotype

    Time frame: 0, 12 months

    Change in proportion and size of type I changes

  5. Disability (Oswestry)

    Time frame: 0, 1, 12 months

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Apr 6, 2011
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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