Chronic Non-bacterial Osteomyelitis Treated With Pamidronate (CNOPAM)
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|ClinicalTrials.gov Identifier: NCT02594878|
Recruitment Status : Unknown
Verified November 2016 by University of Aarhus.
Recruitment status was: Recruiting
First Posted : November 3, 2015
Last Update Posted : November 16, 2016
In a randomized double blind placebo controlled trial to investigate the effect of pamidronate in treatment of chronic non bacterial osteomyelitis.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Immune System Disease Musculoskeletal Disease||Drug: Pamidronatdinatrium Other: Natrium chloride 9mg/ml||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Chronic Non-bacterial Osteomyelitis Treated With Pamidronate in a Randomised Placebo Controlled Trial|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: Pamidronatdinatrium 3mg/ml
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.
Other Name: Pamidronat, Pamifos, Aredia
Placebo Comparator: Natrium chloride 9 mg/ml
Natrium chloride 9 mg/ml volume equals experimental drug
Other: Natrium chloride 9mg/ml
- Wholebody MRI [ Time Frame: Changes between baseline and week 36 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594878
|Contact: Caroline Marie Andreasen, MD||+45 7846 firstname.lastname@example.org|
|Contact: Ellen Margrethe Hauge, Professor||+45 7846 4252|
|Universityhospital of Aarhus, Denmark||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Caroline Marie Andreasen, MD +4578464252 email@example.com|
|Principal Investigator:||Caroline Marie Andreasen, MD||University hospital of Aarhus, Denmark|