Evaluating muscle loss in menopausal women with and without hormone therapy
Evaluation of Sarcopenia in Women in Different Stages of Life and in Hormonal Therapy or Not
This study is trying to see if hormone therapy helps menopausal women keep their muscle strength and mass compared to those who don’t use it and to pre-menopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06792201 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the prevalence of sarcopenia in menopausal women, comparing those receiving hormone replacement therapy (HRT) to those not receiving it, as well as to pre-menopausal women. Participants will be divided into three groups based on their menopausal status and hormone therapy usage. The study will utilize various assessment methods, including the SARC-F questionnaire, handgrip test, chair stand test, and bioimpedance analysis, to evaluate muscle strength and mass. Data will be collected through health records and physical examinations during outpatient visits.
Who should consider this trial
Good fit: Ideal candidates for this study are menopausal women who are either receiving hormone replacement therapy or not, as well as pre-menopausal women of similar age.
Not a fit: Patients who are not menopausal or pre-menopausal women may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of hormone therapy on muscle health in menopausal women.
How similar studies have performed: Other studies have explored sarcopenia in relation to hormonal therapy, indicating that this approach has been previously investigated but may still yield novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Maria C Meriggiola — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Giulia Gava, MD
- Email: gava.giulia@hotmail.it
- Phone: 0512143716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.