Treatment og chronic non bacteriel osteomyelitis with pamidronate

Chronic non bacterial osteomyelitis treated with pamidronat in a randomised placebo controlled trial - CNOPAM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002038-36-DK

Enrollment

Registered

2015-06-08

Start date

2015-08-20

Completion date

Unknown

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic non bacterial osteomyelitis MedDRA version: 19.0 Level: LLT Classification code 10009081 Term: Chronic osteomyelitis System Organ Class: 100000004862

Interventions

Trade Name: Pamidronatdinatrium Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: pamidronat Other descriptive name: PAMIDRONATE DISODIUM Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 1. Reduction of the inflammatory activity in the osteomyelytic boneproces measured by whole body MRIafter 9 months 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 2. Changes in anterior chestwall (adults) in CT scan 3. Changes in patient selfreported pain and life quality 4. Changes in inflammatory markers in blood 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	—

Measure

Time frame

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 1. Reduction of the inflammatory activity in the osteomyelytic boneproces measured by whole body MRIafter 9 months 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 2. Changes in anterior chestwall (adults) in CT scan 3. Changes in patient selfreported pain and life quality 4. Changes in inflammatory markers in blood 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

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Secondary

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

Measure

Time frame

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

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Countries

Denmark

Contacts

Public ContactCaroline Marie Andreasen

Aarhus University Hospital, Department of Rheumatology U

carand@rm.dk+457846 4252

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026