Ten years' experience with alendronate for osteoporosis in postmenopausal women

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dc.contributor.authorBone, HG
dc.contributor.authorHosking, D
dc.contributor.authorDevogelaer, J
dc.contributor.authorTucci, JR
dc.contributor.authorEmkey, RD
dc.contributor.authorTonino, RP
dc.contributor.authorRodriguez Portales, JA
dc.contributor.authorDowns, RW
dc.contributor.authorGupta, J
dc.contributor.authorSantora, AC
dc.contributor.authorLiberman, UA
dc.contributor.authorAlendronate Phase II Osteoporosis
dc.date.accessioned2024-01-10T12:09:13Z
dc.date.available2024-01-10T12:09:13Z
dc.date.issued2004
dc.description.abstractBackground: Antiresorptive agents are widely used to treat osteoporosis. We report the results of a multinational randomized, double-blind study, in which postmenopausal women with osteoporosis were treated with alendronate for up to 10 years.
dc.description.abstractMethods: The initial three-year phase of the study compared three daily doses of alendronate with placebo. Women in the original placebo group received alendronate in years 4 and 5 and then were discharged. Women in the original active-treatment groups continued to receive alendronate during the initial extension (years 4 and 5). In two further extensions (years 6 and 7, and 8 through 10), women who had received 5 mg or 10 mg of alendronate daily continued on the same treatment. Women in the discontinuation group received 20 mg of alendronate daily for two years and 5 mg daily in years 3, 4, and 5, followed by five years of placebo. Randomized group assignments and blinding were maintained throughout the 10 years. We report results for the 247 women who participated in all four phases of the study.
dc.description.abstractResults: Treatment with 10 mg of alendronate daily for 10 years produced mean increases in bone mineral density of 13.7 percent at the lumbar spine (95 percent confidence interval, 12.0 to 15.5 percent), 10.3 percent at the trochanter (95 percent confidence interval, 8.1 to 12.4 percent), 5.4 percent at the femoral neck (95 percent confidence interval, 3.5 to 7.4 percent), and 6.7 percent at the total proximal femur (95 percent confidence interval, 4.4 to 9.1 percent) as compared with base-line values; smaller gains occurred in the group given 5 mg daily. The discontinuation of alendronate resulted in a gradual loss of effect, as measured by bone density and biochemical markers of bone remodeling. Safety data, including fractures and stature, did not suggest that prolonged treatment resulted in any loss of benefit.
dc.description.abstractConclusions: The therapeutic effects of alendronate were sustained, and the drug was well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects.
dc.fechaingreso.objetodigital2024-04-25
dc.format.extent11 páginas
dc.fuente.origenWOS
dc.identifier.doi10.1056/NEJMoa030897
dc.identifier.eissn1533-4406
dc.identifier.issn0028-4793
dc.identifier.pubmedidMEDLINE:15028823
dc.identifier.urihttps://doi.org/10.1056/NEJMoa030897
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/76469
dc.identifier.wosidWOS:000220242400006
dc.information.autorucMedicina;Rodríguez J;S/I;98660
dc.issue.numero12
dc.language.isoen
dc.nota.accesocontenido parcial
dc.pagina.final1199
dc.pagina.inicio1189
dc.publisherMASSACHUSETTS MEDICAL SOC
dc.revistaNEW ENGLAND JOURNAL OF MEDICINE
dc.rightsacceso restringido
dc.subjectBONE-MINERAL DENSITY
dc.subjectHORMONE REPLACEMENT THERAPY
dc.subjectFRACTURE RISK
dc.subjectAMINOBISPHOSPHONATE ALENDRONATE
dc.subjectVERTEBRAL FRACTURES
dc.subjectRANDOMIZED-TRIAL
dc.subjectORAL ALENDRONATE
dc.subjectHIP FRACTURE
dc.subjectESTROGEN
dc.subjectDISCONTINUATION
dc.subject.ods03 Good Health and Well-being
dc.subject.ods05 Gender Equality
dc.subject.odspa03 Salud y bienestar
dc.subject.odspa05 Igualdad de género
dc.titleTen years' experience with alendronate for osteoporosis in postmenopausal women
dc.typeartículo
dc.volumen350
sipa.codpersvinculados98660
sipa.indexWOS
sipa.indexScopus
sipa.trazabilidadCarga SIPA;09-01-2024
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