Oral osmotisches Hydromorphon für die symptomatische Behandlung chronischer Osteoporose bedingter Schmerzen unter alltäglichen Routinebedingungen

Abstract

This prospective, non-interventional study (OROSANA4001) was conducted at 71 sites throughout Germany. 219 adults with chronic pain due to osteoporosis and a pain intensity ≥6 on a numerical rating scale (NRS 0-10) were documented. Pain relief was rated by the patients on a scale from 0% (no relief) to 100% (complete relief) and the interference of pain with general activity was assessed on a scale from 0 to 10. Furthermore, satisfaction with pain therapy (by patient and physician) and patient's capability of physical therapy were evaluated. Tolerability was assessed by documentation of adverse events and study discontinuation. Treatment with oral osmotic hydromorphone decreased all pain intensity ratings significantly from baseline to the last assessment (p<0.0001). Compared to baseline, the physical therapy capability improved significantly (p<0.0001) in 76.3% of patients (n=135). Interference of pain with daily activities also improved significantly (p<0.0001). At the last visit satisfaction with pain control was rated as very satisfied or satisfied by 77% of patients (n=99) and by 80% of physicians (n=104). Adverse events were reported by 70.1% of patients; the most frequent adverse events were constipation (24.3%), nausea (19.2%), fatigue (15%), and dizziness (14%). Treatment with oral osmotic hydromorphone resulted in high treatment satisfaction, and significant pain relief combined with improved physical therapy capability and less interference of pain with daily activities. We conclude that pain management with oral osmotic hydromorphone could potentially have a positive impact on the progression of osteoporosis.