Abstract

Given its increasing incidence and serious complications, osteoporosis requires safe and effective long-term treatment. Strontium ranelate (SR), a new anti-osteoporotic treatment with a unique mode of action, has been investigated in the SOTI (Spinal Osteoporosis Therapeutic Intervention) and the TROPOS (Treatment of Peripheral Osteoporosis) trials, two major 3-year multinational placebo-controlled phase 3 randomized clinical trials. Unlike antiresorptive agents, SR produced steady and significant bone mineral density increases that correlated directly with decreases in vertebral and hip fracture risk. The safety profile of SR was almost similar to placebo in both trials. A slight but significant increased risk of thromboembolism events was noted from the pooled phase 3 studies data. However, this increased was not found in a large retrospective observational study. Thus, SR demonstrates broad spectrum safety and efficacy in reducing the risks of both vertebral and nonvertebral (including hip) fractures in a wide variety of patients, and should be considered as a first-line option to treat women at risk of osteoporotic fractures, whatever their age, the severity of the disease, and their risk factors.

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