NCT02594878

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. 1.Reduction of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
  2. 2.Healing of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
  3. 3.Changes in bone lesions in whole body MRI between baseline and week 12 and between week 12 and week 36
  4. 4.Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between baseline and week 36.
  5. 5.Changes in patient self reported outcome measures
  6. 6.Changes in inflammatory markers and bone markers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

2.6 years

First QC Date

October 20, 2015

Last Update Submit

November 15, 2016

Conditions

Immune System DiseaseMusculoskeletal Disease

Keywords

Chronic non-bacterial osteomyelitisChronic recurrent multifocal osteomyelitisNon- bacterial osteomyelitisSAPHO syndromeWhole body MRIPamidronateInflammatory bone diseaseAutoinflammatory disease

Outcome Measures

Primary Outcomes (1)

  • Wholebody MRI

    Changes between baseline and week 36

Secondary Outcomes (7)

  • CT scan of the anterior chestwall (adults)

    Changes between baseline and week 36

  • Systemic inflammatory markers

    Changes between baseline and week 1, 4, 12, 24 and 36

  • Systemic bone markers

    Changes between baseline and week 1, 4, 12, 24 and 36

  • Wholebody MRI

    Changes between baseline and week 12 and changes between week 12 and 36

  • Changes in Health Assesment Questionnaire score

    Changes between baseline and week 1, 4, 12, 24 and 36

  • +2 more secondary outcomes

Study Arms (2)

Pamidronatdinatrium 3mg/ml

EXPERIMENTAL

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.

Drug: Pamidronatdinatrium

Natrium chloride 9 mg/ml

PLACEBO COMPARATOR

Natrium chloride 9 mg/ml volume equals experimental drug

Other: Natrium chloride 9mg/ml

Interventions

PamidronatdinatriumDRUG
Also known as: Pamidronat, Pamifos, Aredia
Pamidronatdinatrium 3mg/ml
Natrium chloride 9mg/mlOTHER
Natrium chloride 9 mg/ml

Eligibility Criteria

Age9 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 9-65 years (inclusive)
  • Fulfilling the diagnostic criteria for chronic non bacterial osteomyelitis:
  • Mono-, oligo- or multifocal inflammatory bone lesions (osteomyelitis, osteitis, osteosclerosis)
  • Diagnostic score according to A. Jansson criteria (2009) \> 39 or malignancy and infection excluded by biopsy
  • Symptoms \> 6 weeks
  • Volunteer, signed written informed content

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universityhospital of Aarhus, Denmark

Aarhus, 8000, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32484386DERIVED

MeSH Terms

Conditions

Immune System DiseasesMusculoskeletal DiseasesChronic recurrent multifocal osteomyelitisAcquired Hyperostosis SyndromeOsteitis

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Caroline Marie Andreasen, MD

    University hospital of Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Marie Andreasen, MD

CONTACT

+45 7846 4252carand@rm.dk

Ellen Margrethe Hauge, Professor

CONTACT

+45 7846 4252

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

November 3, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

DK(1)