The goal of this observational study is to learn about how well neridronate keeps working in the months after treatment. For 12 or up to 24 months while the registry is open participants will answer online survey questions about their CRPS pain, medication use or procedures done and how CRPS affects what they are able to do.
The primary objective of the registry is to evaluate the long-term effectiveness of IV neridronate across three outcome domains in participants who qualified in CRPS-RISE with early, warm CRPS-1 and a positive triple phase bone scan, following prior treatment with four infusions of neridronate 100 mg IV over approximately a 10-day period. The three outcome domains include, patient report of health status, CRPS-1 related clinical events, and disability status. No neridronate treatment will be given as part of the registry and limited safety information will be collected. Participants will have received neridronate either through CRPS-RISE and/or through the Open Label Extension.
Study Type
OBSERVATIONAL
Enrollment
270
Change from baseline to each registry assessment of average pain in the past 24 hours.
Average pain (24-hour recall) reported on an 11-point numeric rating scale. This is recorded every 90 days from entry.
Time frame: Every 3 months from enrollment until up to 2 years after entry.
Time to loss of benefit where benefit is 50% reduction in average pain intensity from baseline to Week 12 of the CRPS-RISE trial.
Each patient reported registry assessment of average pain in the past 24 hours will use an 11 point numeric rating scale. The analysis will be limited to participants who experienced benefit. Data will be summarized as Kaplan-Meier estimates.
Time frame: Every 3 months from enrollment until up to 2 years after entry.
Change from baseline to each registry assessment in CRPS Severity Score Self-Report (CSS-SR) total score and individual items.
The CSS-SR is designed as a patient self-report questionnaire to assess the severity of CRPS signs and symptoms using plain language to assess 13 concepts.
Time frame: Every 3 months from entry to up to 24 months of participation.
Change from baseline to each registry assessment in Patient Global Impression of Severity (PGI-S).
The 6-point PGI-S is an overall assessment of the participant's perception of the severity of their CRPS condition at the time of the assessment. Participants will respond to the question "How would you rate the symptoms of your CPRS at this time." Possible responses are scored from 0 to 5 representing none, minimal, mild, moderate, severe, very severe.
Time frame: Every 3 months from enrollment until up to 2 years after entry.
Change from baseline to each registry assessment in each of the Short Form 12 Health Survey (SF-12, Acute Version 2) domains, Physical Component Score (PCS), Mental Component Score (MCS), and individual items.
The SF-12 is a widely used measure of general health status used in observational studies across a broad range of disease areas. It is a shortened version of the SF-36 V2.0 and yields 8 domain scores and a Physical Component Summary and Mental Component Summary. Each domain score is calculated by transforming raw responses to a 0-100 scale, where higher scores indicate better health status.
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Time frame: Every 3 months from enrollment until up to 2 years after entry.
Change from baseline to each registry assessment in Daily Sleep Interference Scale (DSIS) in the past 24 hours on an 11-point numeric rating scale.
The DSIS is a single-item scale that assesses "how much did your pain interfere with your sleep during the past 24 hours?" (0 = did not interfere; 10 = completely interfered
Time frame: Every 3 months from enrollment until up to 2 years after entry.
CRPS-1 Related Clinical Events during the 3 months preceding each registry assessment.
The CRPS-1 Treatment Checklist was developed for this registry to assess commonly used pharmacologic treatments (e.g., opioids, neuropathic pain agents, ketamine, NSAIDs, bisphosphonates, corticosteroids, and topicals),interventional procedures (e.g., spinal cord or dorsal root ganglion stimulation, peripheral nerve stimulation, stellate/lumbar sympathetic blocks, sympathetic ablation/sympathectomy, intrathecal pump implant, and Bier block), and non-invasive rehabilitation therapies (e.g., physical therapy, occupational therapy, mirror visual feedback, psychological therapies, scrambler therapies or acupuncture). Participants select all CRPS-related treatments used in the past 3 months. The checklist will also record participation in the open-label clinical trial and is intended for descriptive evaluation of long-term CRPS-1 treatments with a focus on resource intensive events. The outcome domain assesses the long-term effectiveness of neridronate through patient reports.
Time frame: Every 3 months from enrollment until up to 2 years after entry.
Disability Status
During the 3 months preceding each registry assessment the participant reported applying for or being on short-term disability, long-term disability, or workers compensation. As a binary endpoint, it will be summarized as frequencies and percentages. The domain assesses the long-term effectiveness of neridronate through patient reports of short-term disability, long-term disability, and workers compensation.
Time frame: Every 3 months from enrollment until up to 2 years after entry.