Postmenopausal Women, Raloxifene
Conditions
Keywords
raloxifene, coagulation system, von Willebrand factor, Factor 8, vitamin D, protein C, protein S, antithrombin- III, fibrinogen
Brief summary
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.
Interventions
DIAGNOSTIC_TESTcoagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.
Sponsors
Karadeniz Technical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
42 Years to 62 Years
Healthy volunteers
Yes
Inclusion criteria
* In the study planned on patients who have not had menstruation for at least one year, or who have been in menopause naturally or surgically, * the presence of menopause was accepted if the patients' FSH level was\> 40 IU / L. Verbal and written consent was obtained from all patients included in the study.
Exclusion criteria
* . Hypertension, * diabetes mellitus, * hypercholesterolemia, * presence of hepatic-renal-thyroid-parathyroid-adrenal diseases, * cardiovascular, * cerebrovascular and thromboembolic diseases, * undiagnosed vaginal bleeding, * presence of hormone-dependent malignancy or anamnesis, * presence of varicose veins, * chronic drug use that disrupts sex steroid metabolism * cases with smoking * alcohol use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring coagulation parametres | 1 year | After collecting all blood, Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III, and fibrinogen levels were measured in all patients. |
Outcome results
None listed