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

January 14, 2014 updated by: Katri Koivisto, University of Oulu

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90014
        • Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Zometa
  • Aclasta
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:
  • Zometa
  • Aclasta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Low back pain (VAS)
Time Frame: 0, 1, 12 months
0, 1, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2008-005351-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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