Strontium ranelate for preventing and treating postmenopausal osteoporosis

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Abstract

Background: Strontium ranelate is a new treatment for osteoporosis therefore, its benefits and harms need to be known. Objectives: To determine the efficacy and safety of strontium ranelate for the treatment and prevention of postmenopausal osteoporosis. Search methods: We searched MEDLINE (1996-March 2005), EMBASE (1996-week 9 2005), the Cochrane Library (1996-Issue 1 2005), reference lists of relevant articles and conference proceedings from the last two years. Additional data was sought from authors. Selection criteria: We included randomized controlled trials (RCTs) of at least one year duration comparing strontium ranelate to placebo and reporting fracture incidence, bone mineral density (BMD) or adverse events in postmenopausal women. Treatment population was defined as women with prevalent vertebral fractures and/or lumbar spine BMD T-score < -2.5 SD. Data collection and analysis: Two reviewers independently determined study eligibility, assessed study validity, graded the evidence and extracted relevant data. Disagreements were resolved by consensus. RCTs were grouped by dose and treatment duration. Where possible, meta-analysis was conducted using the random effects model. Main results: Four trials met the inclusion criteria. Three had losses to follow-up > 20% and only one provided an adequate description of allocation concealment. Three included a treatment population (0.5 to 2 g/day of strontium ranelate) and one a prevention population (0.125, 0.5 and 1 g/day). A 37% reduction in vertebral fractures (RR 0.63, 95% CI 0.56, 0.71), and a 14% reduction in non-vertebral fractures with the upper boundary of the confidence interval approaching one (RR 0.86, 95% CI 0.75, 0.98), were demonstrated over three years with 2 g of strontium ranelate daily in a treatment population. An increase in BMD was shown at all sites after two to three years of treatment in both populations. Lower doses of strontium ranelate were superior to placebo and the highest dose demonstrated the greatest reduction in vertebral fractures and increase in BMD. An increased risk of diarrhea with 2 g of strontium ranelate daily was found; however, adverse events did not affect the risk of discontinuing treatment nor did it increase the risk of serious side effects, gastritis or death. Additional data suggests that the risk of vascular and nervous system side-effects is increased with taking 2 g of strontium ranelate daily over three to four years. Authors' conclusions: There is silver level evidence (www.cochranemsk.org) to support the efficacy of strontium ranelate for the reduction of fractures (vertebral and to a lesser extent, non-vertebral) in postmenopausal osteoporotic women and an increase in BMD in postmenopausal women with/without osteoporosis. Diarrhea may occur, however, adverse events leading to study withdrawal were not significantly increased. Potential vascular and neurological side-effects need to be further explored.

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O’Donnell, S., Cranney, A., Wells, G. A., Adachi, J., & Reginster, J. Y. (2006, October 18). Strontium ranelate for preventing and treating postmenopausal osteoporosis. Cochrane Database of Systematic Reviews. John Wiley and Sons Ltd. https://doi.org/10.1002/14651858.CD005326.pub3

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