Chronic Non-bacterial Osteomyelitis Treated With Pamidronate

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus

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