Clinical Trial: Chronic Non-bacterial Osteomyelitis Treated With Pamidronate
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Chronic Non-bacterial Osteomyelitis Treated With Pamidronate in a Randomised Placebo Controlled Trial
Brief Summary:
In a randomized double blind placebo controlled trial to investigate the effect of pamidronate in treatment of chronic non bacterial osteomyelitis.
Main objective:
- Reduction of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
- Healing of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
Secondary objectives:
- Changes in bone lesions in whole body MRI between baseline and week 12 and between week 12 and week 36
- Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between baseline and week 36.
- Changes in patient self reported outcome measures
- Changes in inflammatory markers and bone markers.
Detailed Summary:
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.
Sponsor: University of Aarhus
Current Primary Outcome: Wholebody MRI [ Time Frame: Changes between baseline and week 36 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- CT scan of the anterior chestwall (adults) [ Time Frame: Changes between baseline and week 36 ]
- Systemic inflammatory markers [ Time Frame: Changes between baseline and week 1, 4, 12, 24 and 36 ]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
- Systemic bone markers [ Time Frame: Changes between baseline and week 1, 4, 12, 24 and 36 ]s-CTX og s-NTX, P1NP, C1NP, TRACP 5b, bone alkaline phosphatase
- Wholebody MRI [ Time Frame: Changes between baseline and week 12 and changes between week 12 and 36 ]
- Changes in Health Assesment Questionnaire score [ Time Frame: Changes between baseline and week 1, 4, 12, 24 and 36 ]
- Changes in Children Assesment Questionnaire score [ Time Frame: Changes between baseline and week 1, 4, 12, 24 and 36 ]
- Changes in Visual Analog Score for pain [ Time Frame: Changes between baseline and week 1, 4, 12, 24 and 36 ]
Original Secondary Outcome: Same as current
Information By: University of Aarhus
Dates:
Date Received: October 20, 2015
Date Started: October 2015
Date Completion: August 2018
Last Updated: November 15, 2016
Last Verified: November 2016
