Chronic Non-bacterial Osteomyelitis Treated With Pamidronate

NCT ID: NCT02594878

Last Updated: 2016-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-08-31

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.

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.

Conditions

Immune System Disease; Musculoskeletal Disease

Keywords

Chronic non-bacterial osteomyelitis; Chronic recurrent multifocal osteomyelitis; Non- bacterial osteomyelitis; SAPHO syndrome; Whole body MRI; Pamidronate; Inflammatory bone disease; Autoinflammatory disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pamidronatdinatrium

Intervention Type: DRUG

Natrium chloride 9 mg/ml

Natrium chloride 9 mg/ml volume equals experimental drug

Group Type: PLACEBO_COMPARATOR

Natrium chloride 9mg/ml

Intervention Type: OTHER

Interventions

Pamidronatdinatrium

Intervention Type: DRUG

Natrium chloride 9mg/ml

Intervention Type: OTHER

Other Intervention Names

Pamidronat, Pamifos, Aredia

Eligibility 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Marie Andreasen, MD

Role: PRINCIPAL_INVESTIGATOR

University hospital of Aarhus, Denmark

Locations

Universityhospital of Aarhus, Denmark

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Caroline Marie Andreasen, MD

Role: CONTACT

Phone: +45 7846 4252

Email: carand@rm.dk

Ellen Margrethe Hauge, Professor

Role: CONTACT

Phone: +45 7846 4252

Facility Contacts

Caroline Marie Andreasen, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 32484386 (View on PubMed)

Other Identifiers

48438

Identifier Type: -

Identifier Source: org_study_id