drugset / Trial / NCT02594878

Chronic Non-bacterial Osteomyelitis Treated With Pamidronate

NCT02594878

Phase 2 Unknown 32 enrolled University of Aarhus
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-10
Primary completion
2018-05
Completion
2018-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pamidronate Small molecule 1 mg/kg