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In a randomized double blind placebo controlled trial to investigate the effect of pamidronate in treatment of chronic non bacterial osteomyelitis.
Main objective:
Secondary objectives:
Chronic non-bacterial osteomyelitis is a multifocal inflammatory bone disorder. The pathogenesis is unknown. The disease is mainly diagnosed in childhood. There is a strong association with inflammatory disorders of the skin, mainly psoriasis. The disease is characterized by recurrent episodes of pain and disability. It is unclear if SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis) might be the adult version of chronic non-bacterial osteomyelitis. The disease can persist in adulthood and course chronic bone deformations.
Wholebody MRI is the most sensitive imaging for diagnosing and monitoring the non bacterial osteitis.
The treatment of chronic non-bacterial osteomyelitis is largely empiric. First line treatment is NSAID (Non Steroidal Anti-Inflammatory Drug). When NSAID is inadequate the bisphosphonate pamidronate has been described relief pain in small cohorts in retrospective studies.
In this research protocol, investigators seek to investigate if it is beneficial to use pamidronate in the treatment of chronic non bacterial osteomyelitis and the osteitis component in SAPHO syndrome. Primary outcome is whole body MRI. Secondary outcome is CT scan, patient measure reported outcome and biomarkers. A biobank may help us to understand the pathogenesis and future treatment targets of chronic non bacterial osteomyelitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamidronatdinatrium 3mg/ml | Experimental | Pamidronatdinatrium 1 mg/kg max 60 mg for 3 days every 3 month in total of 3 series (0,3,6 month). First day first series 0,5mg/kg max 30 mg. |
|
| Natrium chloride 9 mg/ml | Placebo Comparator | Natrium chloride 9 mg/ml volume equals experimental drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamidronatdinatrium | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wholebody MRI | Changes between baseline and week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| CT scan of the anterior chestwall (adults) | Changes between baseline and week 36 | |
| Systemic inflammatory markers | TNF- α,IL-1 β, IL-8, IL-18, IL-17, INF-ƴ, IL-6, IL-10, IL-11, IL-21, MIP 1-alfa (CCL3, 22) and IL-1Ra |
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Inclusion Criteria:
Age: 9-65 years (inclusive)
Fulfilling the diagnostic criteria for chronic non bacterial osteomyelitis:
Volunteer, signed written informed content
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Marie Andreasen, MD | Contact | +45 7846 4252 | carand@rm.dk | |
| Ellen Margrethe Hauge, Professor | Contact | +45 7846 4252 |
| Name | Affiliation | Role |
|---|---|---|
| Caroline Marie Andreasen, MD | University hospital of Aarhus, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universityhospital of Aarhus, Denmark | Recruiting | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32484386 | Derived | Andreasen CM, Jurik AG, Deleuran BW, Horn HC, Folkmar TB, Herlin T, Hauge EM. Pamidronate in chronic non-bacterial osteomyelitis: a randomized, double-blinded, placebo-controlled pilot trial. Scand J Rheumatol. 2020 Jul;49(4):312-322. doi: 10.1080/03009742.2020.1724324. Epub 2020 Jun 2. |
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009140 | Musculoskeletal Diseases |
| C535456 | Chronic recurrent multifocal osteomyelitis |
| D020083 | Acquired Hyperostosis Syndrome |
| D010000 | Osteitis |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D000077268 | Pamidronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Natrium chloride 9mg/ml |
| Other |
|
| Changes between baseline and week 1, 4, 12, 24 and 36 |
| Systemic bone markers | s-CTX og s-NTX, P1NP, C1NP, TRACP 5b, bone alkaline phosphatase | Changes between baseline and week 1, 4, 12, 24 and 36 |
| Wholebody MRI | Changes between baseline and week 12 and changes between week 12 and 36 |
| Changes in Health Assesment Questionnaire score | Changes between baseline and week 1, 4, 12, 24 and 36 |
| Changes in Children Assesment Questionnaire score | Changes between baseline and week 1, 4, 12, 24 and 36 |
| Changes in Visual Analog Score for pain | Changes between baseline and week 1, 4, 12, 24 and 36 |