NCT02594878: CNOPAM

Chronic Non-bacterial Osteomyelitis Treated With Pamidronate in a Randomised Placebo Controlled Trial

Status unknown Phase 2 Last updated 15 November 2016

What this trial tests

Phase 2 trial testing Pamidronatdinatrium in Immune System Disease in 32 participants. Status unknown.

Timeline

1 October 2015

Primary endpoint
1 May 2018

1 August 2018

Quick facts

Lead sponsor	University of Aarhus
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	32
Start date	1 October 2015
Primary completion	1 May 2018
Estimated completion	1 August 2018
Sites	1 location across Denmark

Drugs / interventions tested

• Pamidronatdinatrium — full drug profile →
• Natrium chloride 9mg/ml

Conditions studied

• Immune System Disease — all drugs for Immune System Disease →
• Musculoskeletal Disease — all drugs for Musculoskeletal Disease →

Sponsor

University of Aarhus

Who can join

Adults 9 to 65, any sex, with Immune System Disease or Musculoskeletal Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Wholebody MRI
  Time frame: Changes between baseline and week 36

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implantable antimicrobial biomaterials for local drug delivery in bone infection models.
   Caplin JD, García AJ. · · 2019 · cited 67× · PMID 30654212 · DOI 10.1016/j.actbio.2019.01.015
2. Pamidronate in chronic non-bacterial osteomyelitis: a randomized, double-blinded, placebo-controlled pilot trial.
   Andreasen CM, Jurik AG, Deleuran BW, Horn HC, et al · · 2020 · cited 28× · PMID 32484386 · DOI 10.1080/03009742.2020.1724324
3. Periodic fever syndromes and the autoinflammatory diseases (AIDs).
   Marino A, Tirelli F, Giani T, Cimaz R. · · 2020 · cited 10× · PMID 32743516 · DOI 10.1016/j.jtauto.2019.100031