[en] 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.
Disciplines :
General & internal medicine
Author, co-author :
Meunier, Pierre J.; Edouard Herriot Hospital > Department of Rheumatology and Bone Disease
Roux, Christian; Cochin Hospital > Department of Rheumatology
Seeman, Ego; Austin Hospital > Endocrine Unit
Ortolani, Sergio; Istituto Auxologico Italiano > Center for Metabolic Bone Disease
Badurski, Janusz E.; Center for Osteoporosis and Osteo-Articular Diseases
Spector, Tim D.; St Thomas' Hospital > Department of Rheumatology
Cannata, Jorge; Central Hospital Asturias > the Mineral and Bone Department
Balogh, Adam; Medical and Health Sciences Center > Department of Obstetrics and Gynecology
Lemmel, Ernst-Martin; Max Grundig Klinik > Innere Medizin–Rheumatology
Pors-Nielsen, Stig; Hillerød Hospital > Department of Clinical Physiology
Rizzoli, René; University Hospital, Geneva > Department of Internal Medicine > Division of Bone Diseases
Genant, Harry K.; University of California > Osteoporosis and Arthritis Group
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique
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