Raloxifene on Coagulation System in the Postmenopausal Women

Sponsor

Karadeniz Technical University (Other)

Overall Status

Completed

CT.gov ID

NCT04454775

Collaborator

(none)

Enrollment

12.6

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Raloxifene Postmenopausal Women	Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Effect of Raloxifene on the Parameters of Coagulation System in the Postmenopausal Women

Actual Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 20, 2006

Arms and Interventions

Arm	Intervention/Treatment
group I 50 cases who received raloxifene and calcium therapy	Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.
group II 30 cases who received only calcium therapy	Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.

Arm

Intervention/Treatment

group I

50 cases who received raloxifene and calcium therapy

Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.

group II

30 cases who received only calcium therapy

Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

42 Years to 62 Years

Sexes Eligible for Study:

Female

Accepts 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.