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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330238
• Other study ID #: EudraCT 2008-005351-14
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2011
• Last updated: January 14, 2014
• Start date: December 2008
• Est. completion date: March 2012

Study information

• Verified date: January 2014
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Zoledronic acid vs. placebo
Single infusion of zoledronic acid or placebo

Locations

Country	Name	City	State
Finland	Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Novartis Pharmaceuticals

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain (VAS)		0, 1, 12 months	No
Secondary	Health-related quality of life (RAND-36)		0, 1, 12 months	No
Secondary	Flexibility of the lumbar spine	Modified Schober measure	0, 1, 12 months	No
Secondary	Sick leaves	Patient-reported	0, 12 months	No
Secondary	Radiologic phenotype	Change in proportion and size of type I changes	0, 12 months	No
Secondary	Disability (Oswestry)		0, 1, 12 months	No