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This version published online on February 22, 2005
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2004-1774
A more recent version of this article appeared on May 1, 2005
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*Fractures
*Osteoporosis
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*THIOPHENE

Submitted on September 12, 2004
Accepted on February 16, 2005

STRONTIUM RANELATE REDUCES THE RISK OF NONVERTEBRAL FRACTURES IN POST-MENOPAUSAL WOMEN WITH OSTEOPOROSIS: TROPOS STUDY

J Y REGINSTER*, E SEEMAN, M C DE VERNEJOUL, S ADAMI, J COMPSTON, C PHENEKOS, J P DEVOGELAER, M DIAZ CURIEL, A SAWICKI, S GOEMAERE, O H SORENSEN, D FELSENBERG, and P J MEUNIER

Department of Epidemiology, Public Health and Health Economics, University of Liège, Liège, BELGIUM; Endocrine Department, Hospital University of Melbourne, Melbourne, AUSTRALIA; INSERM U606 and Fédération of Rheumatologie, Lariboisiere Hospital, Paris, FRANCE; Centro Ospedaliero Clinicizato di Medicina, Riabilitiva e Preventiva di Valeggio, Valeggio Sul Mincio, ITALY; Department of Medicine, University of Cambridge, Cambridge, UNITED KINGDOM; Red Cross Hospital, Department of Endocrinology, Athens, GREECE; Department of Rheumatology - Catholic University of Louvain - Brussels - BELGIUM.; Fundacion Jiménez Diaz, Servicio de Medicina Interna, Unidad de Metabolismo Oseo, Avda. De los Reyes Catolicos 2, Madrid, SPAIN; Warszawskie Centrum Osteoporozy, Bialabrzeska 40A, Warszawa, POLAND; Ghent University Hospital, Unit for Osteoporosis and Metabolic Bone Diseases, De Pintelaan 185, Gent, BELGIUM; The Osteoporosis Research Center, Department 545, Hvidovre University Hospital, Keetegard Alle 30, Hvidovre, DENMARK; Universitätklinikum Benjamin Franklin, Berlin, GERMANY; Department of Rheumatology and Bone Diseases, Edouard Herriot Hospital, Lyon, FRANCE

* To whom correspondence should be addressed. 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 TROPOS study to assess its efficacy and safety in preventing also non-vertebral fractures.

Methods: Strontium ranelate (2 g/day) or placebo were randomly allocated to 5091 postmenopausal women with osteoporosis in a double-blind placebo-controlled 5-year 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 non-vertebral 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 BMD T score ≤ -3) (n = 1977), the relative risk reduction for hip fracture was 36% (P = 0.046). Relative risk 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 BMD throughout the study, reaching at 3 yr (P < 0.001): + 8.2% (femoral neck) and + 9.8% (total hip).

Incidence of adverse events was similar in both groups.

Conclusion: This study shows that strontium ranelate significantly reduces the risk of all non vertebral and in a high risk subgroup, hip fractures over a 3-year 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.
Key words: strontium ranelate • osteoporosis • non-vertebral fractures • hip fracture




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