Postmenopausal Women Clinical Trial
Official title:
The Effect of Raloxifene on the Parameters of Coagulation System in the Postmenopausal Women
Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation
parameters in healthy postmenopausal women.
Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical
University Hospital at gynecology out-patient clinic from December 2005 to December 2006.
Local institutional ethics committee approved our study protocol and written informed consent
was obtained from all participants before enrollment. All patients received daily 600
milligrams of calcium and 400 international units of vitamin D (Cal-D-VİTA, Roche
Switzerland,). 60 milligrams of raloxifene HCI, which is a selective estrogen receptor
modulator (SERM), was added to treatment protocol if patients required hormonal therapy.
Patients receiving raloxifene therapy in addition to calcium and vitamin D therapy formed the
study group(n=50). Control group (n=30) was made up of the patients only receiving calcium
and vitamin D. Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III and
fibrinogen levels were measured in all patients before treatment. These measurements were
repeated at three and twelve months after treatment. Comparisons were performed with Student
t test or Mann Whitney test between the two groups and two-way ANOVA within the groups.
Proportions were compared with Fisher exact or Chi-square tests. Statistically analysis was
done with SPSS packet program (SPSS 11; SPSS Inc.) All p values were two-tailed and p<0.05
was considered statistically significant.
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