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Previous Volume 350:459-468 January 29, 2004 Number 5 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by El-Hajj Fuleihan, G. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption. In a phase 2 clinical trial, strontium ranelate, an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption, has been shown to reduce the risk of vertebral fractures and to increase bone mineral density.

Methods To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial, we randomly assigned 1649 postmenopausal women with osteoporosis (low bone mineral density) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years. We gave calcium and vitamin D supplements to both groups before and during the study. Vertebral radiographs were obtained annually, and measurements of bone mineral density were performed every six months.

Results New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group, with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period (relative risk, 0.59; 95 percent confidence interval, 0.48 to 0.73). Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck (P<0.001 for both comparisons). There were no significant differences between the groups in the incidence of serious adverse events.

Conclusions Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures.

Source Information

From the Department of Rheumatology and Bone Diseases, Edouard Herriot Hospital, Lyons, France (P.J.M.); the Department of Rheumatology, Cochin Hospital, René Descartes University, Paris (C.R.); the Endocrine Unit, Austin Hospital, University of Melbourne, Melbourne, Australia (E.S.); the Center for Metabolic Bone Disease, Istituto Auxologico Italiano, Milan, Italy (S.O.); the Center for Osteoporosis and Osteo-Articular Diseases, Bialystok, Poland (J.E.B.); the Department of Rheumatology, St. Thomas' Hospital, London (T.D.S.); the Mineral and Bone Department, Central Hospital Asturias, Oviedo, Spain (J.C.); the Department of Obstetrics and Gynecology, University of Debrecen, Medical and Health Sciences Center, Debrecen, Hungary (A.B.); Max Grundig Klinik, Innere Medizin–Rheumatology, Bühl, Germany (E.-M.L.); the Department of Clinical Physiology, Hillerød Hospital, Hillerød, Denmark (S.P.-N.); the Division of Bone Diseases, Department of Internal Medicine, University Hospital, Geneva (R.R.); the Osteoporosis and Arthritis Group, University of California, San Francisco (H.K.G.); and the World Health Organization Collaborating Center for Public Health Aspects of Osteoarticular Disorders, Department of Epidemiology and Public Health, University of Liège, Liège, Belgium (J.Y.R.).

Address reprint requests to Dr. Meunier at the Department of Rheumatology and Bone Disease, Pavillon F, Edouard Herriot Hospital, 69437 Lyons CEDEX 03, France, or at pierre.meunier{at}laennec.univ-lyon1.fr.

Full Text of this Article

Related Letters:

Postmenopausal Osteoporosis and Strontium Ranelate
D'Haese P. C., Santacruz F., De Broe M. E., Taur Y., Al-Tureihi F., Wolf-Klein G., Meunier P. J.
Extract | Full Text | PDF  
N Engl J Med 2004; 350:2001-2003, May 6, 2004. Correspondence

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