The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in Women with Postmenopausal Osteoporosis

Pierre J. Meunier, Christian Roux, Ego Seeman, Sergio Ortolani, Janusz E. Badurski, Tim D. Spector, Jorge Cannata, A. Balogh, Ernst Martin Lemmel, Stig Pors-Nielsen, René Rizzoli, Harry K. Genant, Jean Yves Reginster

Research output: Contribution to journalArticle

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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

Original languageEnglish
Pages (from-to)459-468
Number of pages10
JournalNew England Journal of Medicine
Volume350
Issue number5
DOIs
Publication statusPublished - Jan 29 2004

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strontium ranelate
Postmenopausal Osteoporosis
Bone Density
Bone Resorption
Osteogenesis
Placebos
Bone Remodeling
Femur Neck
Risk Reduction Behavior
Vitamin D
Osteoporosis
Spine
Clinical Trials
Confidence Intervals
Calcium
Bone and Bones

ASJC Scopus subject areas

  • Medicine(all)

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Meunier, P. J., Roux, C., Seeman, E., Ortolani, S., Badurski, J. E., Spector, T. D., ... Reginster, J. Y. (2004). The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in Women with Postmenopausal Osteoporosis. New England Journal of Medicine, 350(5), 459-468. https://doi.org/10.1056/NEJMoa022436

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in Women with Postmenopausal Osteoporosis. / Meunier, Pierre J.; Roux, Christian; Seeman, Ego; Ortolani, Sergio; Badurski, Janusz E.; Spector, Tim D.; Cannata, Jorge; Balogh, A.; Lemmel, Ernst Martin; Pors-Nielsen, Stig; Rizzoli, René; Genant, Harry K.; Reginster, Jean Yves.

In: New England Journal of Medicine, Vol. 350, No. 5, 29.01.2004, p. 459-468.

Research output: Contribution to journalArticle

Meunier, PJ, Roux, C, Seeman, E, Ortolani, S, Badurski, JE, Spector, TD, Cannata, J, Balogh, A, Lemmel, EM, Pors-Nielsen, S, Rizzoli, R, Genant, HK & Reginster, JY 2004, 'The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in Women with Postmenopausal Osteoporosis', New England Journal of Medicine, vol. 350, no. 5, pp. 459-468. https://doi.org/10.1056/NEJMoa022436
Meunier, Pierre J. ; Roux, Christian ; Seeman, Ego ; Ortolani, Sergio ; Badurski, Janusz E. ; Spector, Tim D. ; Cannata, Jorge ; Balogh, A. ; Lemmel, Ernst Martin ; Pors-Nielsen, Stig ; Rizzoli, René ; Genant, Harry K. ; Reginster, Jean Yves. / The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in Women with Postmenopausal Osteoporosis. In: New England Journal of Medicine. 2004 ; Vol. 350, No. 5. pp. 459-468.
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