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Efficacy of zoledronic acid 5 mg for chronic low back pain due to Modic changes

Efficacy of zoledronic acid 5 mg for chronic low back pain due to Modic changes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-005351-14-FI
Enrollment
Unknown
Registered
2008-09-01
Start date
2008-10-31
Completion date
Unknown
Last updated
2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Modic changes are vertebral endplate changes and bone marrow changes visible in magnetic resonance imaging (MRI), which are closely assosiated with disc degeneration. Modic changes are assosiated with low back pain (LBP) both in clinical and general population-based studies. No teratment exists for LBP due to Modic changes.

Interventions

Trade Name: Aclasta Product Name: Aclasta/zoledronic acid 5 mg Pharmaceutical Form: Intravenous infusion INN or Proposed INN: ZOLEDRONIC ACID CAS Number: 118072938 Pharmaceutical form of the placebo:

Sponsors

University of Oulu, Department of Physical and Rehabilitation Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) chronic LBP lasting at least 3 months 2) Modic type I or II change in MRI 3) a signed informed consent and 4) intensity of LBP must be at least 6 on a 10-cm VAS or Oswestry disability score exceeding 30% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) premenopausal female patients except when pregnancy is not possible (e.g. hysterectomy) 2) patients with calculated creatine clearance (eGFR) below 40 ml/min 3) patients with hypocalcemia 4) patients with known hypersensitivity to zoledronic acid, other bisphosphonates or ingredients of the infusional product 5) patients with red flags or nerve root entrapment and 6) patients with willingness for early retirement (more than 3 months sick leave during the last year)

Design outcomes

Primary

MeasureTime frame
Main Objective: Bisphosphonates could be effective in Modic changes causing low back pain through two mechanisms: 1.) they could consolidate the vertebral bodies thereby improving the tolerance to mechanical load and 2.) they could disminish inflammation as observed recently in case of ibandronate in an experimental inflammation model;Secondary Objective: ;Primary end point(s): Change in intensity of low back pain (10-cm VAS) from baseline to one year.—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026