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Chronic Non-bacterial Osteomyelitis Treated With Pamidronate

NCT02594878 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-11-16

No results posted yet for this study

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.

Conditions

  • Immune System Disease
  • Musculoskeletal Disease

Interventions

DRUG

Pamidronatdinatrium

OTHER

Natrium chloride 9mg/ml

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Caroline Marie Andreasen, MD · University hospital of Aarhus, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-05-31
Completion
2018-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594878 on ClinicalTrials.gov