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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
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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:

  1. Reduction of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
  2. Healing of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.

Secondary objectives:

  1. Changes in bone lesions in whole body MRI between baseline and week 12 and between week 12 and week 36
  2. Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between baseline and week 36.
  3. Changes in patient self reported outcome measures
  4. 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

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Drug: Pamidronatdinatrium
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



Primary Outcome Measures :
  1. Wholebody MRI [ Time Frame: Changes between baseline and week 36 ]

Secondary Outcome Measures :
  1. CT scan of the anterior chestwall (adults) [ Time Frame: Changes between baseline and week 36 ]
  2. 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

  3. 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

  4. Wholebody MRI [ Time Frame: Changes between baseline and week 12 and changes between week 12 and 36 ]
  5. Changes in Health Assesment Questionnaire score [ Time Frame: Changes between baseline and week 1, 4, 12, 24 and 36 ]
  6. Changes in Children Assesment Questionnaire score [ Time Frame: Changes between baseline and week 1, 4, 12, 24 and 36 ]
  7. Changes in Visual Analog Score for pain [ Time Frame: Changes between baseline and week 1, 4, 12, 24 and 36 ]


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Ages Eligible for Study:   9 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 9-65 years (inclusive)
  • Fulfilling the diagnostic criteria for chronic non bacterial osteomyelitis:

    1. Mono-, oligo- or multifocal inflammatory bone lesions (osteomyelitis, osteitis, osteosclerosis)
    2. Diagnostic score according to A. Jansson criteria (2009) > 39 or malignancy and infection excluded by biopsy
    3. Symptoms > 6 weeks
  • Volunteer, signed written informed content

Exclusion Criteria:

  • Age older than 65 years
  • Age younger than 9 years
  • Pregnant women or nursing (breastfeeding) mothers
  • Hypersensitivity to pamidronate, bisphosphonate og additives in pamidronate
  • Known history or current lymphoproliferative disease
  • History of surgery on glandula thyroidea
  • Known alcohol/medical abuse
  • Poor dental status
  • Low Vitamin D- status
  • Liver/ kidney disease
  • Abnormal laboratory screening for comorbidity

Information from the National Library of Medicine

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


Contacts
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Contact: Caroline Marie Andreasen, MD +45 7846 4252 carand@rm.dk
Contact: Ellen Margrethe Hauge, Professor +45 7846 4252

Locations
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Denmark
Universityhospital of Aarhus, Denmark Recruiting
Aarhus, Denmark, 8000
Contact: Caroline Marie Andreasen, MD    +4578464252    carand@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Caroline Marie Andreasen, MD University hospital of Aarhus, Denmark

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02594878     History of Changes
Other Study ID Numbers: 48438
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Keywords provided by University of Aarhus:
Chronic non-bacterial osteomyelitis
Chronic recurrent multifocal osteomyelitis
Non- bacterial osteomyelitis
SAPHO syndrome
Whole body MRI
Pamidronate
Inflammatory bone disease
Autoinflammatory disease
Additional relevant MeSH terms:
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Osteomyelitis
Musculoskeletal Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases