UNLABELLED: Strontium ranelate reduces the risk of fracture in post-menopausal osteoporotic women with prevalent fractures for whom quality of life is severely impaired. The SOTI study, which used the SF-36 questionnaire and disease-specific QUALIOST module, demonstrated that treatment with strontium ranelate improved osteoporotic women's quality of life compared with placebo. INTRODUCTION: The Spinal Osteoporosis Therapeutic Intervention (SOTI) study demonstrated the effect of orally administered strontium ranelate versus placebo on the incidence of new vertebral fractures and compared impact on quality of life (QoL). METHODS:QoL was assessed 6 monthly over 3 years using the QUALIOST and SF-36 questionnaires in post-menopausal osteoporotic women with prevalent fracture takingstrontium ranelate or placebo 2 g/day. A total of 1,240 women were included (strontium ranelate: n=618 and placebo: n=622). RESULTS: The QUALIOST total score decreased in the strontium ranelate group, indicating preserved QoL compared with a deterioration in the placebo group (P=0.016). Strontium ranelate patients had reduced QUALIOST emotional and physical dimension scores (P=0.019 and 0.032, respectively, versus placebo), indicating beneficial effects on emotional and physical functioning. There was a trend towards better SF-36 scores in the strontium ranelate group, although there were no significant between-group differences. More strontium ranelate patients (+31%) were free from back pain over 3 years versus placebo (P=0.005), with a significant effect from the first year of treatment (P=0.023). CONCLUSION:Strontium ranelate has beneficial effects on QoL in women with post-menopausal osteoporosis compared with placebo.
RCT Entities:
UNLABELLED: Strontium ranelate reduces the risk of fracture in post-menopausal osteoporoticwomen with prevalent fractures for whom quality of life is severely impaired. The SOTI study, which used the SF-36 questionnaire and disease-specific QUALIOST module, demonstrated that treatment with strontium ranelate improved osteoporoticwomen's quality of life compared with placebo. INTRODUCTION: The Spinal Osteoporosis Therapeutic Intervention (SOTI) study demonstrated the effect of orally administered strontium ranelate versus placebo on the incidence of new vertebral fractures and compared impact on quality of life (QoL). METHODS: QoL was assessed 6 monthly over 3 years using the QUALIOST and SF-36 questionnaires in post-menopausal osteoporoticwomen with prevalent fracture taking strontium ranelate or placebo 2 g/day. A total of 1,240 women were included (strontium ranelate: n=618 and placebo: n=622). RESULTS: The QUALIOST total score decreased in the strontium ranelate group, indicating preserved QoL compared with a deterioration in the placebo group (P=0.016). Strontium ranelatepatients had reduced QUALIOST emotional and physical dimension scores (P=0.019 and 0.032, respectively, versus placebo), indicating beneficial effects on emotional and physical functioning. There was a trend towards better SF-36 scores in the strontium ranelate group, although there were no significant between-group differences. More strontium ranelatepatients (+31%) were free from back pain over 3 years versus placebo (P=0.005), with a significant effect from the first year of treatment (P=0.023). CONCLUSION:Strontium ranelate has beneficial effects on QoL in women with post-menopausal osteoporosis compared with placebo.
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