To compare the efficacy and safety of aceclofenac in the treatment of back pain in patients with osteoporosis.
Material and methods
In the open-label study, 40 women with definite osteoporosis and back pain (age 50 to 85 years, average age of 69±7 years) were randomly distributed into two groups and treated with aceclofenac suspension (100 mg twice daily) or meloxicam tablets (15 mg once daily) for 14 days. To evaluate the efficacy of treatment, we studied changes in the intensity of pain (visual analogue scale), the need to lie to relieve pain (the number and total duration of episodes), health-related quality of life and functional disability (EQ-5D and the Oswestry questionnaire). At 30 days, we contacted all patients by phone to evaluate the need in additional intake of non-steroid antiinflammatory drugs within the next 16 days.
At 14 days, intensity of back pain improved significantly in both groups of patients (p<0.001). Treatment with both medications resulted in reduced need to lie to avoid back pain. Physical activity and immobility improved in 14 (70%) and 10 (50%) patients in the aceclofenac group, and 11 (55%) and8 (40%) patientsinmeloxicamgroup, respectively. There was similar improvement in health-related quality of life in patients treated with aceclofenac and meloxicam. However, changes in functional activity were more prominent after treatment with aceclofenac. At 14 days, 13 (65%) females assessed the efficacy of aceclofenac as excellent or good. All patients completed treatment with aceclofenac while meloxicam was discontinued due to adverse events in 3 (15%) patients.
Aceclofenac is effective and well-tolerated medication in patients with osteoporosis and back pain. The results of treatment were excellent or good in 65% of women treated with aceclofenac.
Оsteoporsis, back pain, aceclofenac.