Chronic nonbacterial osteitis (CNO) in adults
Conditions
Interventions
Trade Name: Pamipro 3 mg/ml
Product Name: Pamidronate
Pharmaceutical Form: Infusion
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients with an established diagnosis of CNO based on clinical and imaging features. - NRS score for maximal pain of 6/10 or higher at lesion sites* - Signs of disease activity on imaging at lesion sites - No treatment with bisphosphonates for the previous 6 months ** * If the patient uses co-medication possibly targeting CNO-related pain, i.e. paracetamol, NSAIDs, opioids, DMARDs and biologicals on stable dosage, score for maximal pain should be 6/10 or higher despite the use of these medication(s) . Co-medication can be continued throughout the study and will be periodically monitored by the researcher. **For bisphosphonates, a pre-specified wash-out period of 6 months is indicated before inclusion in the study. Biologicals and steroids that are discontinued in a regular care setting (so not continued as co-medication) prior to inclusion in the study also require a pre-specified wash-out period prior to inclusion (as specified in Standard Operating Procedure Washout Periods). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Age below 18 years of age - Active pregnancy wish, pregnancy or nursing - Generalized pain without CNO related pain - Bisphosphonate allergy - Estimated glomerular filtration rate < 30 ml/min - Uncontrolled endocrine abnormalities - Active cancer treatment. - Language barrier - Severe co-morbidity, including poor mobility and other causes preventing attendance for control visits - Mental disability NB: In case of poor dental hygiene or inadequate dental care, patients will only be enrolled after oral maxillary surgeon consultation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that in CNO patients with pain 3-monthly treatment with pamidronate will result in a significant decrease in maximal pain score (as measured by Brief Pain Inventory (BPI), compared to placebo.;Secondary Objective: To study the number of patients with mild pain (>4 on BPI) after 3-monthly treatment with pamidronate, the number of patients with 50% reduction in maximal pain (NRS score in BPI), change in shoulder rating questionnaire (SRQ) and facets of Shoulder function assessment (SFA) score (among which is ability to dress), change in range of motion, improvement in general health as measured with Short Form Health Survey (Sf-36), work activity score , and physical activity, partner burden, change in standard dose of analgesics during course of the study as evidence for efficacy of treatment. Evaluation of confounding factors for outcome of treatment, alteration of inflammation and quantifiable decrease in Na18F-PET/CT tracer uptake of CNO lesions after pamidronate therapy. Evaluation of a possible neuropathic pain and central pain sensitization and association with response. To assess spinal involvement of CNO-lesions, and cost-effectiveness of therapy in an economic evaluation.;Primary end point(s): Change in score of maximal pain on BPI (NRS 0-10) from baseline to 6 months (adjusted for baseline).;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in range of motion • Number of patients with mild pain (maximal pain as measured with NRS score in BPI =4) • Number of patients with 50% reduction in maximal pain (NRS score in BPI) • Change in shoulder rating questionnaire and facets of SFA score (among which are ability to dress) • Change in general health, quality of life, fatigue, work activity score, physical activity, and partner burden • Change in standard dose of analgesics (including NSAIDs) possible during course of the study as evidence for efficacy of treatment. • Evaluation of confounding factors for outcome of treatment such as delay in diagnosis and the amount of baseline tracer uptake, pain and range of motion • Evaluation of a possible neuropathic component of the reported pain • Number of CNO patients exhibiting signs of central sensitization • Association between central sensitization and therapeutic response • Change in biochemical markers of inflammation • Amount of tracer uptake of CNO lesions on Na18F-PET/CT • Spinal involvement • Cost-effectiveness;Timepoint(s) of evaluation of this end point: 0, 3, 6, 9 12 months | — |
Countries
Netherlands
Contacts
Public ContactLUMC department of Endocrinology
Leiden University Medical Center
Outcome results
None listed