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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Zoledronic acid vs. placebo

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Modic changes, Vertebral endplate signal changes, Efficacy, Zoledronic acid, Bisphosphonates, RCT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zoledronic acid

Placebo

Arm Description

Single infusion of 5 mg zoledronic acid I.V.

Single infusion of 100 ml isotonic NaCl-solution I.V.

Outcomes

Primary Outcome Measures

Low back pain (VAS)

Secondary Outcome Measures

Health-related quality of life (RAND-36)

Flexibility of the lumbar spine

Modified Schober measure

Sick leaves

Patient-reported

Radiologic phenotype

Change in proportion and size of type I changes

Disability (Oswestry)

Full Information

NCT ID

NCT01330238

First Posted

February 11, 2011

Last Updated

January 14, 2014

Sponsor

University of Oulu

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01330238

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Oulu

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Low back pain, Modic changes, Vertebral endplate signal changes, Efficacy, Zoledronic acid, Bisphosphonates, RCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zoledronic acid

Arm Type

Active Comparator

Arm Description

Single infusion of 5 mg zoledronic acid I.V.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Single infusion of 100 ml isotonic NaCl-solution I.V.

Intervention Type

Drug

Intervention Name(s)

Zoledronic acid vs. placebo

Other Intervention Name(s)

Aclasta, Zometa

Intervention Description

Single infusion of zoledronic acid or placebo

Primary Outcome Measure Information:

Title

Low back pain (VAS)

Time Frame

0, 1, 12 months

Secondary Outcome Measure Information:

Title

Health-related quality of life (RAND-36)

Time Frame

0, 1, 12 months

Title

Flexibility of the lumbar spine

Description

Modified Schober measure

Time Frame

0, 1, 12 months

Title

Sick leaves

Description

Patient-reported

Time Frame

0, 12 months

Title

Radiologic phenotype

Description

Change in proportion and size of type I changes

Time Frame

0, 12 months

Title

Disability (Oswestry)

Time Frame

0, 1, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: