Immune System DiseasePhase 2CNOPAMNCT02594878
Chronic Non-bacterial Osteomyelitis Treated With Pamidronate
A Phase 2 study testing Pamidronatdinatrium and Natrium chloride 9mg/ml in people with Immune System Disease and Musculoskeletal Disease, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 65 years
- Conditions the study is for
- Immune System Disease, Musculoskeletal Disease
- What is being tested?
- Pamidronatdinatrium and Natrium chloride 9mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Known alcohol/medical abuse
- Poor dental status
- Low Vitamin D- status
- Liver/ kidney disease
- Abnormal laboratory screening for comorbidity
Trial locations and contacts
1 site in 1 country.
Ellen Margrethe Hauge, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Universityhospital of Aarhus, Denmark
Aarhus, 8000
Caroline Marie Andreasen, MD, +4578464252, carand@rm.dk
About this study
Official title: Chronic Non-bacterial Osteomyelitis Treated With Pamidronate in a Randomised Placebo Controlled Trial
In a randomized double blind placebo controlled trial to investigate the effect of pamidronate in treatment of chronic non bacterial osteomyelitis.
Main objective:
- Reduction of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
- Healing of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
Secondary objectives:
- Changes in bone lesions in whole body MRI between baseline and week 12 and between week 12 and week 36
- Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between baseline and week 36.
- Changes in patient self reported outcome measures
- Changes in inflammatory markers and bone markers.
Read the detailed description
Chronic non-bacterial osteomyelitis is a multifocal inflammatory bone disorder. The pathogenesis is unknown. The disease is mainly diagnosed in childhood. There is a strong association with inflammatory disorders of the skin, mainly psoriasis. The disease is characterized by recurrent episodes of pain and disability. It is unclear if SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis) might be the adult version of chronic non-bacterial osteomyelitis. The disease can persist in adulthood and course chronic bone deformations.
Wholebody MRI is the most sensitive imaging for diagnosing and monitoring the non bacterial osteitis.
The treatment of chronic non-bacterial osteomyelitis is largely empiric. First line treatment is NSAID (Non Steroidal Anti-Inflammatory Drug). When NSAID is inadequate the bisphosphonate pamidronate has been described relief pain in small cohorts in retrospective studies.
In this research protocol, investigators seek to investigate if it is beneficial to use pamidronate in the treatment of chronic non bacterial osteomyelitis and the osteitis component in SAPHO syndrome. Primary outcome is whole body MRI. Secondary outcome is CT scan, patient measure reported outcome and biomarkers. A biobank may help us to understand the pathogenesis and future treatment targets of chronic non bacterial osteomyelitis.
- Conditions
- Immune System Disease, Musculoskeletal Disease
- Being tested
- Pamidronatdinatrium, Natrium chloride 9mg/ml
- Keywords
- Chronic non-bacterial osteomyelitis, Chronic recurrent multifocal osteomyelitis, Non- bacterial osteomyelitis, SAPHO syndrome, Whole body MRI, Pamidronate, Inflammatory bone disease, Autoinflammatory disease
- Medical subject headings
- Immune System Diseases, Musculoskeletal Diseases, Chronic recurrent multifocal osteomyelitis, Acquired Hyperostosis Syndrome, Osteitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamidronatdinatriumDrug
Also called Pamidronat, Pamifos, Aredia
Natrium chloride 9mg/mlOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pamidronatdinatrium |
| Natrium chloride 9 mg/ml | Placebo comparator | Natrium chloride 9 mg/ml volume equals experimental drug Receives: Other: Natrium chloride 9mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wholebody MRI
Measured: Changes between baseline and week 36
Secondary outcomes (7)
CT scan of the anterior chestwall (adults)
Measured: Changes between baseline and week 36
Systemic inflammatory markers
TNF- α,IL-1 β, IL-8, IL-18, IL-17, INF-ƴ, IL-6, IL-10, IL-11, IL-21, MIP 1-alfa (CCL3, 22) and IL-1Ra
Measured: Changes between baseline and week 1, 4, 12, 24 and 36
Systemic bone markers
s-CTX og s-NTX, P1NP, C1NP, TRACP 5b, bone alkaline phosphatase
Measured: Changes between baseline and week 1, 4, 12, 24 and 36
Wholebody MRI
Measured: Changes between baseline and week 12 and changes between week 12 and 36
Changes in Health Assesment Questionnaire score
Measured: Changes between baseline and week 1, 4, 12, 24 and 36
Changes in Children Assesment Questionnaire score
Measured: Changes between baseline and week 1, 4, 12, 24 and 36
Changes in Visual Analog Score for pain
Measured: Changes between baseline and week 1, 4, 12, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune System DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Marie Andreasen, MD, Principal investigator, University hospital of Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594878
- Sponsor's protocol ID
- 48438
- Acronym
- CNOPAM
- Status last verified
- Nov 2016
- First submitted
- 20 Oct 2015
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32484386
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Non-bacterial Osteomyelitis Treated With Pamidronate in a Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02594878
- Acronym / sponsor ID
- CNOPAM / 48438
- Conditions
- Immune System Disease, Musculoskeletal Disease
- Keywords
- Chronic non-bacterial osteomyelitis, Chronic recurrent multifocal osteomyelitis, Non- bacterial osteomyelitis, SAPHO syndrome, Whole body MRI, Pamidronate, Inflammatory bone disease, Autoinflammatory disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a randomized double blind placebo controlled trial to investigate the effect of pamidronate in treatment of chronic non bacterial osteomyelitis.
Main objective:
- Reduction of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
- Healing of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
Secondary objectives:
- Changes in bone lesions in whole body MRI between baseline and week 12 and between week 12 and week 36
- Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between baseline and week 36.
- Changes in patient self reported outcome measures
- Changes in inflammatory markers and bone markers.
Detailed description
Chronic non-bacterial osteomyelitis is a multifocal inflammatory bone disorder. The pathogenesis is unknown. The disease is mainly diagnosed in childhood. There is a strong association with inflammatory disorders of the skin, mainly psoriasis. The disease is characterized by recurrent episodes of pain and disability. It is unclear if SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis) might be the adult version of chronic non-bacterial osteomyelitis. The disease can persist in adulthood and course chronic bone deformations.
Wholebody MRI is the most sensitive imaging for diagnosing and monitoring the non bacterial osteitis.
The treatment of chronic non-bacterial osteomyelitis is largely empiric. First line treatment is NSAID (Non Steroidal Anti-Inflammatory Drug). When NSAID is inadequate the bisphosphonate pamidronate has been described relief pain in small cohorts in retrospective studies.
In this research protocol, investigators seek to investigate if it is beneficial to use pamidronate in the treatment of chronic non bacterial osteomyelitis and the osteitis component in SAPHO syndrome. Primary outcome is whole body MRI. Secondary outcome is CT scan, patient measure reported outcome and biomarkers. A biobank may help us to understand the pathogenesis and future treatment targets of chronic non bacterial osteomyelitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pamidronatdinatrium 3mg/ml | Experimental | Drug: PamidronatdinatriumPamidronatdinatrium 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. |
| Natrium chloride 9 mg/ml | Placebo comparator | Other: Natrium chloride 9mg/mlNatrium chloride 9 mg/ml volume equals experimental drug |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 9-65 years (inclusive)
- Fulfilling the diagnostic criteria for chronic non bacterial osteomyelitis:
- Volunteer, signed written informed content
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PamidronatdinatriumAlso: Pamidronat, Pamifos, Aredia | Drug | Pamidronatdinatrium 3mg/ml |
| Natrium chloride 9mg/ml | Other | Natrium chloride 9 mg/ml |
Primary outcome
Wholebody MRI
Time frame: Changes between baseline and week 36
7 secondary outcomes
CT scan of the anterior chestwall (adults)
Time frame: Changes between baseline and week 36
Systemic inflammatory markers
Time frame: Changes between baseline and week 1, 4, 12, 24 and 36
Systemic bone markers
Time frame: Changes between baseline and week 1, 4, 12, 24 and 36
Wholebody MRI
Time frame: Changes between baseline and week 12 and changes between week 12 and 36
Changes in Health Assesment Questionnaire score
Time frame: Changes between baseline and week 1, 4, 12, 24 and 36
Changes in Children Assesment Questionnaire score
Time frame: Changes between baseline and week 1, 4, 12, 24 and 36
Changes in Visual Analog Score for pain
Time frame: Changes between baseline and week 1, 4, 12, 24 and 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Derived from this study: PubMed 32484386Andreasen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Margrethe Hauge, Professor contact
Caroline Marie Andreasen, MD principal investigator
University hospital of Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pamidronatdinatrium and Natrium chloride 9mg/ml in people with Immune System Disease and Musculoskeletal Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Marie Andreasen, MD (+45 7846 4252, carand@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wholebody MRI (time frame: Changes between baseline and week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016; AzTrials last refreshed its copy on 3 Nov 2026.