NCT01330238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_2 low-back-pain

Timeline
Completed

Started Dec 2008

Typical duration for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

February 11, 2011

Last Update Submit

January 14, 2014

Conditions

Low Back Pain

Keywords

Low back painModic changesVertebral endplate signal changesEfficacyZoledronic acidBisphosphonatesRCT

Outcome Measures

Primary Outcomes (1)

  • Low back pain (VAS)

    0, 1, 12 months

Secondary Outcomes (5)

  • Health-related quality of life (RAND-36)

    0, 1, 12 months

  • Flexibility of the lumbar spine

    0, 1, 12 months

  • Sick leaves

    0, 12 months

  • Radiologic phenotype

    0, 12 months

  • Disability (Oswestry)

    0, 1, 12 months

Study Arms (2)

Zoledronic acid

ACTIVE COMPARATOR

Single infusion of 5 mg zoledronic acid I.V.

Drug: Zoledronic acid vs. placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Zoledronic acid vs. placebo

Interventions

Zoledronic acid vs. placeboDRUG

Single infusion of zoledronic acid or placebo

Also known as: Aclasta, Zometa
PlaceboZoledronic acid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oulu, 90014, Finland

Location

Related Publications (2)

  • Koivisto K, Jarvinen J, Karppinen J, Haapea M, Paananen M, Kyllonen E, Tervonen O, Niinimaki J. The effect of zoledronic acid on type and volume of Modic changes among patients with low back pain. BMC Musculoskelet Disord. 2017 Jun 23;18(1):274. doi: 10.1186/s12891-017-1632-z.

    PMID: 28645291DERIVED

  • Koivisto K, Kyllonen E, Haapea M, Niinimaki 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.

    PMID: 24588905DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jaro Karppinen, Prof

    University of Oulu

    STUDY CHAIR

  • Katri Koivisto, MD

    University of Oulu

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Physical and Rehabilitation Medicine

Study Record Dates

First Submitted

February 11, 2011

First Posted

April 6, 2011

Study Start

December 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

FI(1)