Continuous broad protection against osteoporotic fractures with strontium ranelate.

Abstract

Among the available agents for osteoporosis, anti-resorptive drugs do not increase bone formation, whereas anabolic agents do not reduce bone resorption. Strontium ranelate (SR) uniquely does both, rebalancing bone turnover in favour of bone formation. In the Spinal Osteoporosis Therapeutic Intervention (SOTI) study, a 4-year trial, SR treatment reduced vertebral fracture risk by 33% (P < 0.001), and symptomatic vertebral fracture risk by 36% (P < 0.001). SR also significantly improved quality of life as assessed by the Quality-of-Life Questionnaire in Osteoporosis (QUALIOST) instrument. In the Treatment of Peripheral Osteoporosis Study (TROPOS) study, a 5-year trial, SR significantly reduced total fracture risk by 20% (29.1 vs 33.9%; P < 0.001), total non-vertebral fracture risk by 15% (18.6 vs 20.9%; P = 0.032) and hip fracture risk by 43% (7.2 vs 10.2%; P = 0.036) in the subgroup that is at high risk for hip fracture. Analysis of pooled data from these two studies found that SR is also safe and effective in patients aged >or=80 years, reducing the risk of vertebral fracture over 5 years by 31% (P = 0.010) and non-vertebral fracture by 26% (P = 0.019). Adherence to treatment in the trials exceeded 80%, and the adverse event profile of SR was similar to that of placebo. Taken together, these long-term findings clearly demonstrate that SR is safe and effective in reducing both vertebral and non-vertebral (particularly hip) fracture risks for at least 5 years of pre-planned follow-up.