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: January 14, 2014
Last verified: January 2014

February 11, 2011
January 14, 2014
December 2008
March 2011   (final data collection date for primary outcome measure)
Low back pain (VAS) [ Time Frame: 0, 1, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01330238 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
Drug: Zoledronic acid vs. placebo
Single infusion of zoledronic acid or placebo
Other Names:
  • Aclasta
  • Zometa
  • Active Comparator: Zoledronic acid
    Single infusion of 5 mg zoledronic acid I.V.
    Intervention: Drug: Zoledronic acid vs. placebo
  • Placebo Comparator: Placebo
    Single infusion of 100 ml isotonic NaCl-solution I.V.
    Intervention: Drug: Zoledronic acid vs. placebo
Koivisto K, Kyllönen E, Haapea M, Niinimäki J, Sundqvist K, Pehkonen T, Seitsalo S, Tervonen O, Karppinen J. Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging. BMC Musculoskelet Disord. 2014 Mar 4;15:64. doi: 10.1186/1471-2474-15-64.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2012
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01330238
EudraCT 2008-005351-14
No
Katri Koivisto, University of Oulu
University of Oulu
Novartis Pharmaceuticals
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
University of Oulu
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP