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Department of Epidemiology (J.Y.R.), Public Health and Health Economics, University of Liège, 4020 Liège, Belgium; Endocrine Department (E.S.), Hospital University of Melbourne, 3084 Melbourne, Australia; Institut National de la Santé et de la Recherche Médicale Unité 606 and Fédération of Rheumatologie (M.C.D.V.), Lariboisiere Hospital, 75010 Paris, France; Centro Ospedaliero Clinicizato di Medicina, Riabilitiva e Preventiva di Valeggio (S.A.), 37067 Valeggio Sul Mincio, Italy; Department of Medicine (J.C.), University of Cambridge, Cambridge, CB2 2QQ United Kingdom; Department of Endocrinology (C.P.), Red Cross Hospital, 11526 Athens, Greece; Department of Rheumatology (J.P.D.), Catholic University of Louvain, 1200 Brussels, Belgium; Fundacion Jiménez Diaz (M.D.C.), Servicio de Medicina Interna, Unidad de Metabolismo Oseo, 28040 Madrid, Spain; Warszawskie Centrum Osteoporozy (A.S.), 00-632 Warszawa, Poland; Unit for Osteoporosis and Metabolic Bone Diseases (S.G.), Ghent University Hospital, 9000 Gent, Belgium; The Osteoporosis Research Center (O.H.S.), Department 545, Hvidovre University Hospital, 2650 Hvidovre, Denmark; Universitätklinikum Benjamin Franklin (D.F.), 12200 Berlin, Germany; Department of Rheumatology and Bone Diseases (P.J.M.), Edouard Herriot Hospital, 69372 Lyon, France
Address all correspondence and requests for reprints to: Prof. J. Y. Reginster, Department of Epidemiology, Public Health and Health Economics, University of Liège, CHU Centre ville, 45 Quai Godefroid Kurth, 4020 Liège, Belgium. E-mail: jyreginster{at}ulg.ac.be.
Background: Strontium ranelate, a new oral drug shown to reduce vertebral fracture risk in postmenopausal women with osteoporosis, was studied in the Treatment of Peripheral Osteoporosis (TROPOS) study to assess its efficacy and safety in preventing nonvertebral fractures also.
Methods: Strontium ranelate (2 g/d) or placebo were randomly allocated to 5091 postmenopausal women with osteoporosis in a double-blind placebo-controlled 5-yr study with a main statistical analysis over 3 yr of treatment.
Findings: In the entire sample, relative risk (RR) was reduced by 16% for all nonvertebral fractures (P = 0.04), and by 19% for major fragility fractures (hip, wrist, pelvis and sacrum, ribs and sternum, clavicle, humerus) (P = 0.031) in strontium ranelate-treated patients in comparison with the placebo group. Among women at high risk of hip fracture (age 
74 yr and femoral neck bone mineral density T score 
–3, corresponding to –2.4 according to NHANES reference) (n = 1977), the RR reduction for hip fracture was 36% (P = 0.046). RR of vertebral fractures was reduced by 39% (P < 0.001) in the 3640 patients with spinal x-rays and by 45% in the subgroup without prevalent vertebral fracture.
Strontium ranelate increased bone mineral density throughout the study, reaching at 3 yr (P < 0.001): +8.2% (femoral neck) and +9.8% (total hip).
Incidence of adverse events (AEs) was similar in both groups.
Conclusion: This study shows that strontium ranelate significantly reduces the risk of all nonvertebral and in a high-risk subgroup, hip fractures over a 3-yr period, and is well tolerated. It confirms that strontium ranelate reduces vertebral fractures. Strontium ranelate offers a safe and effective means of reducing the risk of fracture associated with osteoporosis.
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