Zoledronic acid, an osteoporosis drug, in chronic low back pain with specific findings on magnetic resonance imaging: a randomized controlled trial

ZOLEDRONIC ACID, A LONG-ACTING BISPHOSPHONATE, FOR CHRONIC LOW BACK PAIN DUE TO MODIC CHANGES: A RANDOMIZED CONTROLLED TRIAL - ZAMOD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000751-25-FI

Enrollment

250

Registered

2015-12-08

Start date

2016-05-02

Completion date

Unknown

Last updated

2024-10-21

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

Conditions

Chronic low back pain MedDRA version: 18.1 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859

Interventions

Product Name: Disodium Zoledronate Tetrahydrate Product Code: AXS-02 Pharmaceutical Form: Tablet INN or Proposed INN: Disodium Zoledronate Tetrahydrate CAS Number: 165800-07-7 Current Sponsor code: AX

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Low back pain lasting at least 3 months Disabling low back pain (intensity at least 6 on a 0-10 scale or disability on Oswestry Disability Index at least 30%) An inflammatory Modic change on MRI 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 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Red flags, recents spine surgery, severe renal impairment

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of orally administered ZA 50 mg once a week for 6 weeks among patients with chronic LBP and MC on MRI.;Secondary Objective: Safety of zoledronic acid;Primary end point(s): Low back pain intensity ;Timepoint(s) of evaluation of this end point: 3 months	—

Secondary

Measure	Time frame
Secondary end point(s): Disability, work ability, health care use, safety ;Timepoint(s) of evaluation of this end point: One year	—

Countries

Finland, Hong Kong, India

Contacts

Public ContactJaro Karppinen

University of Oulu

jaro.karppinen@ttl.fi

Outcome results

None listed

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