Clinical trial NCT01330238: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Low back pain
Modic changes
Vertebral endplate signal changes
Efficacy
Zoledronic acid
Bisphosphonates
RCT
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Low back pain (VAS)
timeFrame: 0, 1, 12 months
Secondary outcomes:
measure: Health-related quality of life (RAND-36)
timeFrame: 0, 1, 12 months
measure: Flexibility of the lumbar spine
timeFrame: 0, 1, 12 months
measure: Sick leaves
timeFrame: 0, 12 months
measure: Radiologic phenotype
timeFrame: 0, 12 months
measure: Disability (Oswestry)
timeFrame: 0, 1, 12 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu
Study officials:
affiliation: University of Oulu
name: Jaro Karppinen, Prof
role: STUDY_CHAIR
affiliation: University of Oulu
name: Katri Koivisto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Oulu
name: Eero Kyllönen, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Oulu
name: Kaj Sundqvist, MD
role: STUDY_DIRECTOR
affiliation: University of Oulu
name: Jaakko Niinimäki, MD
role: STUDY_DIRECTOR
affiliation: University of Oulu
name: Osmo Tervonen, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.