Clinical trial NCT06792201: Evaluation of Sarcopenia in Women in Different Stages of Life and in Hormonal Therapy or Not
Official title: Evaluation of Sarcopenia in Women in Different Stages of Life and in Hormonal Therapy or Not
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Menopause
Hormonal therapy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Strength and muscle mass outcomes
timeFrame: From enrollment to the end of treatment (1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maria C Meriggiola
role: PRINCIPAL_INVESTIGATOR
References: