Pamidronate disodium for Sternocostoclavicular hyperostosis | Chronic nonbacterial osteitis | Inflammation of sternal region

Inclusion criteria

• {"criterion_text":"- NRS score for maximal pain of ≥ 6/10 at lesion sites\n- Signs of disease activity on imaging at lesion sites\n- No treatment with bisphosphonates for the previous 6 months"}

Exclusion criteria

• {"criterion_text":"- Age below 18 years of age\n- Mental disability\n- Active pregnancy wish, pregnancy or nursing\n- Generalized pain without CNO related pain\n- Bisphosphonate allergy\n- Estimated glomerular filtration rate < 30 ml/min\n- Uncontrolled endocrine abnormalities\n- Active cancer treatment\n- Language barrier\n- Severe co-morbidity, including poor mobility and other causes preventing attendance for control visits"}

Primary endpoints

• {"endpoint_text":"- Change in score of maximal pain on BPI (NRS 0-10) from baseline to 6 months","definition_or_measurement_approach":"Change from baseline to 6 months measured by Brief Pain Inventory (BPI) maximal pain score using an NRS 0-10."}

Secondary endpoints

• {"endpoint_text":"- Change in range of motion","definition_or_measurement_approach":"Change in range of motion measured by clinical assessment (as specified in secondary objectives/endpoints)."}
• {"endpoint_text":"- Number of patients with mild pain (maximal pain as measured with NRS score in BPI ≤4)","definition_or_measurement_approach":"Count of patients whose maximal pain on BPI (NRS) is ≤4 at the specified timepoint (3 months/6 months as per objectives)."}
• {"endpoint_text":"- Number of patients with 50% reduction in maximal pain (NRS score in BPI)","definition_or_measurement_approach":"Proportion of patients achieving ≥50% reduction in maximal pain on BPI (NRS) compared to baseline."}
• {"endpoint_text":"- Change in shoulder rating questionnaire and facets of SFA score (among which are ability to dress)","definition_or_measurement_approach":"Change in Shoulder Rating Questionnaire (SRQ) and Shoulder Function Assessment (SFA) scores from baseline."}
• {"endpoint_text":"- Change in general health, quality of life, fatigue, work activity score, physical activity, and partner burden","definition_or_measurement_approach":"Measured using SF-36, work activity score, IPAQ (short form), and CarerQol for partner burden; change from baseline assessed."}
• {"endpoint_text":"- Change in standard dose of analgesics (including NSAIDs) possible during course of the study as evidence for efficacy of treatment","definition_or_measurement_approach":"Assessment of changes in analgesic dosing (including NSAIDs) over study duration compared to baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Analysis of baseline factors (diagnostic delay, baseline tracer uptake, pain, ROM) as potential confounders for outcomes."}
• {"endpoint_text":"- Evaluation of a possible neuropathic component of the reported pain","definition_or_measurement_approach":"Assessment using PainDETECT questionnaire to evaluate neuropathic pain components."}
• {"endpoint_text":"- Number of CNO patients exhibiting signs of central sensitization","definition_or_measurement_approach":"Assessment using Central Sensitization Inventory (CSI); count of patients meeting criteria for central sensitization."}
• {"endpoint_text":"- Association between central sensitization and therapeutic response","definition_or_measurement_approach":"Correlation/association analysis between CSI scores and treatment response (including primary outcome)."}
• {"endpoint_text":"- Change in biochemical markers of inflammation","definition_or_measurement_approach":"Evaluation of inflammatory biomarkers over time compared to baseline (specific markers not detailed in summary)."}
• {"endpoint_text":"- Amount of tracer uptake of CNO lesions on Na18F-PET/CT","definition_or_measurement_approach":"Quantification of Na18F-PET/CT tracer uptake in CNO lesions and change from baseline."}
• {"endpoint_text":"- Spinal involvement","definition_or_measurement_approach":"Assessment of presence/extent of spinal involvement of CNO lesions (imaging-based)."}
• {"endpoint_text":"- Cost-effectiveness","definition_or_measurement_approach":"Economic evaluation to assess cost-effectiveness of therapy (methods not detailed in summary)."}

Netherlands

Earliest CTIS Part Ii Submission Date

25-07-2024

Latest Decision Or Authorization Date

16-01-2025

Processing Time Days

175

Number Of Sites

1

Number Of Participants

70

Primary sponsor

Full Name

Academisch Ziekenhuis Leiden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Reuma Nederland","duties_or_roles":"Monetary support","organisation_type":""}