Effectiveness and tolerability of tapentadol PR in the management of vertebral fracture pain due to bone fragility

Background: Fragility fractures are frequent complications of osteoporosis and are associated with acute pain that very often evolves into chronic pain. MetHOdS: this prospective, open-label, single-center, observational study evaluated effectiveness and tolerability of tapentadol prolonged release and assessed the association of tapentadol treatment with sleep quality, physical well-being, patient satisfaction and quality of life in patients with pain after vertebral fracture due to bone fragility. RESULTS: Among 35 patients, a total of 29 (83%) achieved a ≥30% reduction of pain intensity and 13 (37%) patients showed a reduction of the pain on movement and at rest ≥50% after 180 days of treatment. A total of 24 adverse events occurred in 16 patients (46%), 15 of them were mild and nine were moderate, the most frequent events were headache and sleepiness. Sleep quality, physical well-being, Brief pain inventory Questionnaire scores and SF12 Questionnaire scores significantly improved (P<0.01) at the end of the treatment. All patients were “satisfied” or “very satisfied” with the treatment after 20 days. CONCLUSIONS: These results highlighted the beneficial effects of tapentadol prolonged release in terms of pain intensity reduction, quality of life and functionality in patients with vertebral fracture caused by bone fragility.