Treatment og chronic non bacteriel osteomyelitis with pamidronate

Phase 1

Active, not recruiting

Conditions: Chronic non bacterial osteomyelitis
MedDRA version: 19.0Level: LLTClassification code 10009081Term: Chronic osteomyelitisSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2015-002038-36-DK

Lead Sponsor: Aarhus University Hospital, Department of Rheumatology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

1.Mono-, oligo- eller multifocal inflammatory bonelesions (osteomyelitis, osteitis, osteosclerosis)
2.Diagnostic score iaccording to Jansson criteria > 39 or malignancy and infnfection excluded by biopsi
3.Symptoms > 6 weeks

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In a randomized double blind placebo controlled design in patients with chronic non bacterial osteomyelitis to investigate whether it is possible by treating with pamidronat to achieve a<br>1. Reduction of the inflammatory activity in the osteomyelytic boneproces measured by whole body MRIafter 9 months<br>2. Healing of the inflammatory activity in the osteomyelytic boneproces measured by whole body MRI after 9 months;Secondary Objective: 1. Changes in osteomyelitic bonelesions in WB MRI<br>2. Changes in anterior chestwall (adults) in CT scan <br>3. Changes in patient selfreported pain and life quality<br>4. Changes in inflammatory markers in blood<br>5. Changes in bonemarkers in blood;Primary end point(s): Changes in the osteomyelitc bonelesion measured by activity and healing on WB MRI;Timepoint(s) of evaluation of this end point: Evaluation 9 months after first pamidronat treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. WB MRI changes in osteomyelitic bonelesions (bonemarrowedema, periosteal reaction, fatinfiltration)<br>2. CT changes in anterior chestwall (adults) (hyperostosis, periosteal element)<br>3. Changes in PROM ( HAQ, SF-36, EQ5D score, CHAQ- 38, PedQL, PCQ, VAS score)<br>4. Changes in inflammatory markers in blood<br>5. Changes in bonemarkers in blood;Timepoint(s) of evaluation of this end point: Secondary endpoint will be evaluated at month 3,6, 9