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

Tracking Information

First Received Date ^ICMJE

February 11, 2011

Last Updated Date

April 5, 2012

Start Date ^ICMJE

December 2008

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01330238 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase 2 Study of the Efficacy of Zoledronic Acid in Low Back Pain Related to Vertebral Endplate Signal Changes, the So-called Modic Changes

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Drug: Zoledronic acid vs. placebo

Single infusion of zoledronic acid or placebo

Other Names:

Aclasta
Zometa

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01330238

Other Study ID Numbers ^ICMJE

EudraCT 2008-005351-14

Has Data Monitoring Committee

Responsible Party

Katri Koivisto, University of Oulu

Study Sponsor ^ICMJE

University of Oulu

Collaborators ^ICMJE

Novartis Pharmaceuticals

Investigators ^ICMJE

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

Information Provided By

University of Oulu

Verification Date

April 2012

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

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