Recent pooled analyses have shown that strontium ranelate increases the incidence of venous thromboembolism and non-fatal myocardial infarction, but no explanations were given. The aim of our study was to assess the effects a 12-month treatment with strontium ranelate on hemostasis factors and markers of cardiovascular risk in postmenopausal osteoporotic women. Forty osteoporotic postmenopausal women received orally strontium ranelate 2 g daily, plus calcium and colecalcipherol for 12 months. Forty postmenopausal osteopenic women matched for age, menopausal age, and body mass index served as controls and received orally calcium and colecalcipherol for 12 months. Biochemical cardiovascular risk factors and hemostatic indices were assayed prior to treatment, and after 3, 6, and 12 months of therapy. These indices included fibrinogen, fasting glucose, total serum cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, plasma levels of D-dimer, homocysteine, partial thromboplastin time, and prothrombin time. In addition, we evaluated possible changes in blood pressure and occurrence of venous thromboembolic events. At baseline, no statistically significance was observed between the two groups except for bone mineral density at lumbar spine, femoral neck, and total femur, which was lower in strontium ranelate group. After 12 months of treatment, there was no statistically significant change in cardiovascular risk factors and hemostatic parameters. None of the 40 women developed any clinical venous thromboembolic event. A 12-month treatment with strontium ranelate did not alter hemostasis factors or markers of cardiovascular risk, suggesting that reported increased risk of venous thromboembolism and myocardial infarction with strontium is mediated by other factors.
Keywords: Cardiovascular risk; Hemostatic system; Osteoporosis; Safety; Strontium ranelate.