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Background Tibolone has estrogenic, progestogenic, and androgenic effects. Although tibolone prevents bone loss, its effects on fractures, breast cancer, and cardiovascular disease are uncertain.
Methods In this randomized study, we assigned 4538 women, who were between the ages of 60 and 85 years and had a bone mineral density T score of –2.5 or less at the hip or spine or a T score of –2.0 or less and radiologic evidence of a vertebral fracture, to receive once-daily tibolone (at a dose of 1.25 mg) or placebo. Annual spine radiographs were used to assess for vertebral fracture. Rates of cardiovascular events and breast cancer were adjudicated by expert panels.
Results During a median of 34 months of treatment, the tibolone group, as compared with the placebo group, had a decreased risk of vertebral fracture, with 70 cases versus 126 cases per 1000 person-years (relative hazard, 0.55; 95% confidence interval [CI], 0.41 to 0.74; P<0.001), and a decreased risk of nonvertebral fracture, with 122 cases versus 166 cases per 1000 person-years (relative hazard, 0.74; 95% CI, 0.58 to 0.93; P=0.01). The tibolone group also had a decreased risk of invasive breast cancer (relative hazard, 0.32; 95% CI, 0.13 to 0.80; P=0.02) and colon cancer (relative hazard, 0.31; 95% CI, 0.10 to 0.96; P=0.04). However, the tibolone group had an increased risk of stroke (relative hazard, 2.19; 95% CI, 1.14 to 4.23; P=0.02), for which the study was stopped in February 2006 at the recommendation of the data and safety monitoring board. There were no significant differences in the risk of either coronary heart disease or venous thromboembolism between the two groups.
Conclusions Tibolone reduced the risk of fracture and breast cancer and possibly colon cancer but increased the risk of stroke in older women with osteoporosis. (ClinicalTrials.gov number, NCT00519857
[ClinicalTrials.gov]
.)
Source Information
From the San Francisco Coordinating Center and the California Pacific Medical Center Research Institute (S.R.C.) and the University of California, San Francisco (S.R.C., B.E.) — all in San Francisco; Université de Lyon and INSERM Research Unit 831, Lyon, France (P.D.D.); Amsterdam Free University Hospital, Amsterdam (P.K.); Organon, Roseland, NJ (V.S.), and Oss, the Netherlands (P.V., M.M.-A., L.K., W.S.); the College of Physicians and Surgeons, Columbia University, New York (L.M.); the Center for Clinical and Basic Research, Ballerup, Denmark (C.C.); New York–Presbyterian Hospital, Columbia University, and Cornell University, New York (J.B.); the National Reference Center on Osteoporosis, Hospital J.M. Ramos Mejía, Buenos Aires (E.M.K.); Carver College of Medicine, University of Iowa, Iowa City (S.J.); Instituto de Investigationes Metabólicas, Buenos Aires (J.Z.); the Julius Center for Health Sciences and Primary Care, Utrecht University Hospital, Utrecht, the Netherlands (D.E.G.); and the University of Sheffield, Sheffield, United Kingdom (R.E.).
Related Letters:
Tibolone in Older Postmenopausal Women
Chlebowski R. T., Prentice R., Serati M., Uccella S., Bolis P., Cummings S. R., Stathopolous V.
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N Engl J Med 2008;
359:2172-2173, Nov 13, 2008.
Correspondence
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