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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic acid | Active Comparator | Single infusion of 5 mg zoledronic acid I.V. |
|
| Placebo | Placebo Comparator | Single infusion of 100 ml isotonic NaCl-solution I.V. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid vs. placebo | Drug | Single infusion of zoledronic acid or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low back pain (VAS) | 0, 1, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life (RAND-36) | 0, 1, 12 months | |
| Flexibility of the lumbar spine | Modified Schober measure | 0, 1, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu | Oulu | 90014 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28645291 | Derived | 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. | |
| 24588905 | Derived | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Sick leaves |
Patient-reported |
| 0, 12 months |
| Radiologic phenotype | Change in proportion and size of type I changes | 0, 12 months |
| Disability (Oswestry) | 0, 1, 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |