Raloxifene on Coagulation System in the Postmenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Women; Raloxifene
• Intervention / Treatment: Diagnostic test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.

• Study Type: Observational
• Enrollment (Actual): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 62 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who applied to Menopause outpatient clinic with the approval of Karadeniz Technical University Faculty of Medicine Ethics Committee numbered 2005/47 were evaluated within the scope of the prospective study. Working time was determined as 12 months.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring coagulation parametres	After collecting all blood, Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III, and fibrinogen levels were measured in all patients.	1 year

Collaborators and Investigators

• Sponsor: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2005
• Primary Completion (ACTUAL): December 1, 2006
• Study Completion (ACTUAL): December 20, 2006

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: vitamin D; fibrinogen; raloxifene; protein C; von Willebrand factor; coagulation system; Factor 8; protein S; antithrombin- III
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Serine Proteinase Inhibitors; Anticoagulants; Antithrombins; Antithrombin III; Protein C; Protein S
• Other Study ID Numbers: 2005/47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No