Objective: To assess the prevalence of skeletal pain in postmenopausal women before the onset of raloxifene treatment and the further course of pain during treatment in a naturalistic setting.
Research design and methods: Prospective, uncontrolled, multicentre, 6-month, observational study in Germany. Clinical, diagnostic and pain data were collected at baseline, 6 weeks and 6 months of raloxifene treatment from 3299 female outpatients with postmenopausal osteoporosis. Physicians assessed the presence or absence of back pain, joint pain and diffuse bone pain at each visit, perceived sleep quality and the use of analgesics. Patients assessed intensity and frequency of pain using a 100 mm visual analogue scale (VAS) and a 5-point scale (from 'rarely' to 'permanently'), respectively.
Results: At baseline, patients had mean (SD) age 67.6 (9.3) years, 89.4% were reported to have reduced bone mineral density, 39.8% had pre-existing fractures and 93.4% had skeletal pain (physician assessment): 85.1% had back pain, 41.8% joint pain and 32.5% diffuse bone pain. Median pain intensity on VAS was 66.0 mm. After 6 months of raloxifene treatment, the frequency and intensity of pain and use of analgesics for skeletal pain decreased consistently by approximately 50%. Pain frequency decreased in 58.2% and increased in 2.3% of patients. The median decrease in pain intensity from baseline to 6 months was 27.0 mm (46%). Patients' subjective quality of sleep improved: the proportion of patients who were reported to sleep well increased from 21.3% at baseline to 46.7% at 6 months. The decrease in relative pain frequency was greatest with diffuse pain (67.6%) followed by joint pain (36.9%) and back pain (32.5%).
Conclusion: Raloxifene treatment in postmenopausal women with osteoporosis was associated with a marked reduction of skeletal pain and analgesic consumption and an improvement in subjective sleep quality. Further investigation in a randomised, placebo-controlled trial is warranted.