Evaluation of Sarcopenia in Women in Different Stages of Life and in Hormonal Therapy or Not

Not Applicable

Recruiting

• Conditions: Sarcopenia

• Registration Number: NCT06792201
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The three-year interventional study has the following objectives:

The study aims to assess the prevalence of sarcopenia in menopausal women receiving hormone replacement therapy or not compared with pre-menopausal women. The study population will be divided into groups according to the intake or not of hormonal therapy of menopause as per normal clinical practice and the menopausal state:

GROUP A - menopausal patient taking hormone therapy GROUP B - menopausal patient not taking hormone therapy GROUP C - pre-menopausal patients who do not take hormonal products The primary objective is to compare the strength and muscle mass outcomes of HRT in menopausal women compared with those who do not use it and women in pre-menopausal age. Survey methods such as SARC-F, Handgrip test, Chair stand test and bio impedance

Detailed Description

The present one-center cross-sectional observational study involves the recruitment of patients attending the O.U. of Gynecology and Pathophysiology of Human Reproduction in menopause who take or do not take hormone replacement therapy at the time of the first visit and women in pre-menopause but similar age group compared to the first group.

Patients will be asked to participate in this study during the outpatient follow-up visit.

The study will involve data collection through consultation of health records.

The objectives of the study will therefore be achieved by analysing certain parameters that can be deduced from the medical records of the subjects in the study:

* Collection of anamnestic (eating habits and sports, pathologies of importance, medication intake, previous surgical interventions, smoking habit, gynecological history).

* Physical examination: calculation of BMI, blood pressure measurement, gynecological examination

* Blood tests (blood count, lipid profile, glycemic, liver, kidney, hormonal status) and urine

* Reports of other visits and specialist examinations performed by the patients brought to view during the visit

* During the visit, the following tests will be proposed:

Questionnaire SARC-F Handgrip test Chair stand test bioimpedance Study population

Inclusion criteria:

* Patients attending the O.U. of Gynecology and Human Reproduction Pathophysiology in menopause who take or do not take hormone replacement therapy at the time of the first visit and women in pre-menopause.

* Patients for whom informed consent has been obtained. Exclusion criteria: no exclusion criteria are provided

Visits and evaluations Visits and assessment scheme Each patient will be invited to participate in this study at the usual outpatient checkup according to current clinical practice. Patients will be free to decide whether or not to participate in the study

Information will be collected from the patients attending the U.O. of Gynecology and Pathophysiology of Human Reproduction in menopause who take or do not take hormone replacement therapy at the time of the first visit and women in pre-menopausemenopause but similar age group compared to the first group.

An estimated sample of 180 subjects.

Study Timeline

• Study Start: 2021-06-14
• Status Verified: 2024-11
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-06-14
• Study Completion: 2026-06-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Patients attending the O.U. of Gynecology and Pathophysiology of Human Reproduction in menopause who take or do not take hormone replacement therapy at the time of visit as normal clinical practice and women in pre-menopause.

Patients for whom informed consent has been obtained.

Exclusion Criteria

• no exclusion criteria are provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Strength and muscle mass outcomes	From enrollment to the end of treatment (1 year)	The primary objective is to compare the strength and muscle mass outcomes of HRT in menopausal women compared with those who do not use it and women in pre-menopausal age. Survey methods such as SARC-F, Handgrip test, Chair stand test and bio impedance will be used for this purpose.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria Bologna; 🇮🇹 Bologna, Italy