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Objective: To investigate changes in back pain in postmenopausal women with severe osteoporosis who received teriparatide for 24 months or switched at 12 months to raloxifene or no active treatment. Study design and methods: This prospective, controlled, randomised, open-label, 2-year study enrolled 868 postmenopausal women with osteoporosis and a recent fragility fracture. After 12 months of teriparatide (20g/day), 507 patients were randomised to further teriparatide (n305), raloxifene 60mg/day (n100), or no active treatment (n102) for another 12 months (substudy 1); in substudy 2, 199 patients continued teriparatide. All received calcium and vitamin D supplementation. Back pain was self-assessed by patients using a visual analogue scale (0100mm). Changes in back pain were analysed using a mixed model for repeated measures. Results: During year 1, back pain decreased from a mean (SD) of 48.9mm (24.0) at baseline by 11.5mm (p |
