Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
Healthy Volunteers
ID06792201

Study of Sarcopenia in Women at Different Life Stages Comparing Muscle Strength and Mass with or without Hormone Therapy

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-24

180

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating sarcopenia, a condition involving loss of muscle mass and strength, in women at different life stages, including menopausal women who are and are not receiving hormone replacement therapy (HRT), as well as pre-menopausal women. The study aims to compare muscle strength and mass outcomes among these groups to understand the effects of HRT and menopausal status. This observational study includes women aged 18 to 65 attending a gynecology clinic. Participants will be divided into three groups: menopausal women taking HRT, menopausal women not taking HRT, and pre-menopausal women not using hormonal products. Various tests will be used to assess muscle strength and mass, including the SARC-F questionnaire, handgrip test, chair stand test, and bioimpedance measurement. These methods evaluate physical function and estimate lean muscle mass safely and easily. During their visit, participants will undergo a physical exam, blood pressure measurement, gynecological exam, and blood and urine tests. Researchers will also collect health history information such as diet, exercise, smoking, medications, and prior surgeries. Outcomes will focus on strength and muscle mass changes over one year. Data will be gathered through clinical records and direct testing, with an estimated 180 women expected to participate.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women attending the Gynecology and Human Reproduction clinic who are menopausal and taking hormone replacement therapy at the time of visit
  • Women attending the clinic who are menopausal and not taking hormone replacement therapy at the time of visit
  • Women attending the clinic who are pre-menopausal
  • Women aged between 18 and 65 years
  • Women who have provided informed consent to participate
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

G

Giulia Gava, MD

M

Maria C Meriggiola, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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