Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis: Results of a five-year, randomized, placebo-controlled trial
Autor: | Stefan Goemaere, Kim Brixen, Adolfo Diez-Perez, Dieter Felsenberg, Steven Boonen, C. Cormier, Adam Balogh, Maria Luisa Brandi, Jean-Yves Reginster, René Rizzoli, Pierre D. Delmas, Pierre J. Meunier, Tim D. Spector |
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Rok vydání: | 2008 |
Předmět: |
Thiophenes/therapeutic use
medicine.medical_specialty Bone Density Conservation Agents/therapeutic use Immunology Osteoporosis Placebo-controlled study Thiophenes Fractures Bone Double-Blind Method Rheumatology Strontium ranelate Organometallic Compounds medicine Fractures Bone/prevention & control Humans Immunology and Allergy Pharmacology (medical) Raloxifene Longitudinal Studies Risk factor Spinal Injuries/prevention & control Osteoporosis Postmenopausal Aged Femoral neck Aged 80 and over Hip fracture Bone Density Conservation Agents Hip Fractures business.industry Osteoporosis Postmenopausal/drug therapy medicine.disease Surgery Treatment Outcome medicine.anatomical_structure Spinal Injuries Relative risk ddc:618.97 Hip Fractures/prevention & control Female Organometallic Compounds/therapeutic use business medicine.drug |
Zdroj: | Arthritis and Rheumatism, Vol. 58, No 6 (2008) pp. 1687-95 Reginster, J-Y, Felsenberg, D, Boonen, S, Diez-Perez, A, Rizzoli, R, Brandi, M-L, Spector, T D, Brixen, K, Goemaere, S, Cormier, C, Balogh, A, Delmas, P D & Meunier, P J 2008, ' Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis : Results of a five-year, randomized, placebo-controlled trial ', Arthritis & Rheumatism, vol. 58, no. 6, pp. 1687-1695 . https://doi.org/10.1002/art.23461 |
ISSN: | 1529-0131 0004-3591 |
Popis: | Udgivelsesdato: 2008-Jun OBJECTIVE: This study was undertaken to assess the effect of strontium ranelate on nonvertebral and vertebral fractures in postmenopausal women with osteoporosis in a 5-year, double-blind, placebo-controlled trial. METHODS: A total of 5,091 postmenopausal women with osteoporosis were randomized to receive either strontium ranelate at 2 gm/day or placebo for 5 years. The main efficacy criterion was the incidence of nonvertebral fractures. In addition, incidence of hip fractures was assessed, by post hoc analysis, in the subset of 1,128 patients who were at high risk of fractures (age 74 years or older with lumbar spine and femoral neck bone mineral density T scores -2.4 or less). The incidence of new vertebral fractures was assessed, using the semiquantitative method described by Genant, in the 3,646 patients in whom spinal radiography (a nonmandatory procedure) was performed during the course of the study. Fracture data were analyzed using the Kaplan-Meier survival method. RESULTS: Of the 5,091 patients, 2,714 (53%) completed the study up to 5 years. The risk of nonvertebral fracture was reduced by 15% in the strontium ranelate group compared with the placebo group (relative risk 0.85 [95% confidence interval 0.73-0.99]). The risk of hip fracture was decreased by 43% (relative risk 0.57 [95% confidence interval 0.33-0.97]), and the risk of vertebral fracture was decreased by 24% (relative risk 0.76 [95% CI 0.65-0.88]) in the strontium ranelate group. After 5 years, the safety profile of strontium ranelate remained unchanged compared with the 3-year findings. CONCLUSION: Our findings indicate that treatment of postmenopausal osteoporosis with strontium ranelate results in a sustained reduction in the incidence of osteoporotic nonvertebral fractures, including hip fractures, and vertebral fractures over 5 years. |
Databáze: | OpenAIRE |
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