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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Katri Koivisto, University of Oulu
ClinicalTrials.gov Identifier:
NCT01330238
First received: February 11, 2011
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Low back pain (VAS) [ Time Frame: 0, 1, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life (RAND-36) [ Time Frame: 0, 1, 12 months ] [ Designated as safety issue: No ]
  • Flexibility of the lumbar spine [ Time Frame: 0, 1, 12 months ] [ Designated as safety issue: No ]
    Modified Schober measure

  • Sick leaves [ Time Frame: 0, 12 months ] [ Designated as safety issue: No ]
    Patient-reported

  • Radiologic phenotype [ Time Frame: 0, 12 months ] [ Designated as safety issue: No ]
    Change in proportion and size of type I changes

  • Disability (Oswestry) [ Time Frame: 0, 1, 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 11, 2011
Last Updated: April 5, 2012
Health Authority: Finland: Ethics Committee
United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013