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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330238
First Posted: April 6, 2011
Last Update Posted: January 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Katri Koivisto, University of Oulu
  Purpose
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.

Condition Intervention Phase
Low Back Pain Drug: Zoledronic acid vs. placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Katri Koivisto, University of Oulu:

Primary Outcome Measures:
  • Low back pain (VAS) [ Time Frame: 0, 1, 12 months ]

Secondary Outcome Measures:
  • Health-related quality of life (RAND-36) [ Time Frame: 0, 1, 12 months ]
  • Flexibility of the lumbar spine [ Time Frame: 0, 1, 12 months ]
    Modified Schober measure

  • Sick leaves [ Time Frame: 0, 12 months ]
    Patient-reported

  • Radiologic phenotype [ Time Frame: 0, 12 months ]
    Change in proportion and size of type I changes

  • Disability (Oswestry) [ Time Frame: 0, 1, 12 months ]

Enrollment: 40
Study Start Date: December 2008
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zoledronic acid
Single infusion of 5 mg zoledronic acid I.V.
Drug: Zoledronic acid vs. placebo
Single infusion of zoledronic acid or placebo
Other Names:
  • Aclasta
  • Zometa
Placebo Comparator: Placebo
Single infusion of 100 ml isotonic NaCl-solution I.V.
Drug: Zoledronic acid vs. placebo
Single infusion of zoledronic acid or placebo
Other Names:
  • Aclasta
  • Zometa

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330238


Locations
Finland
Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Novartis Pharmaceuticals
Investigators
Study Chair: Jaro Karppinen, Prof University of Oulu
Principal Investigator: Katri Koivisto, MD University of Oulu
Study Director: Eero Kyllönen, MD University Hospital of Oulu
Study Director: Kaj Sundqvist, MD University Hospital of Oulu
Study Director: Jaakko Niinimäki, MD University of Oulu
Study Director: Osmo Tervonen, Prof. University of Oulu
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katri Koivisto, Specialist in Physical and Rehabilitation Medicine, University of Oulu
ClinicalTrials.gov Identifier: NCT01330238     History of Changes
Other Study ID Numbers: EudraCT 2008-005351-14
First Submitted: February 11, 2011
First Posted: April 6, 2011
Last Update Posted: January 15, 2014
Last Verified: January 2014

Keywords provided by Katri Koivisto, University of Oulu:
Low back pain
Modic changes
Vertebral endplate signal changes
Efficacy
Zoledronic acid
Bisphosphonates
RCT

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs