RecruitingACTRN12617000584336

The effects of cross-sex hormone therapy on bone microarchitecture in transgender individuals

The effects of cross-sex hormone therapy on bone microarchitecture in transgender individuals. A prospective controlled observational study.

Sponsor

Austin Health

Enrollment

160 participants

Start Date

May 16, 2017

Study Type

Observational

Conditions

Transgender

Summary

This is a prospective observational study looking at bone health in transgender individuals. The purpose of this study is to investigate the changes that occur during cross sex hormone therapy for gender dysphoria, in particular changes to the architecture of bones but also to muscle mass, fat mass, cardiovascular risk factors and quality of life. We will recruit participants just about to start on hormone therapy (i.e. have not previously taken gender hormones in the past) . We plan to review participants 5 times over a 2 year period and will be using DXA/body composition scans as well as a specialised bone CT scan. We will also be performing blood tests and quality of life surveys.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at how hormone therapy for transgender individuals affects their bones, muscles, fat, and heart health over two years. If you are an adult who is about to start hormone therapy for gender dysphoria and have never used gender hormones before, you may be able to join. The study will involve regular scans, blood tests, and health surveys. You may be eligible if: - You are 18 years old or older - You have a diagnosis of gender dysphoria - You are about to start cross-sex hormone therapy for the first time You may NOT be eligible if: - You have ever used cross-sex hormone therapy or anti-androgen medicines before - You have established osteoporosis, liver disease, or a history of blood clots - You are pregnant - You have any serious illness likely to affect the study Talk to your doctor about whether this trial might be right for you.

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Interventions

This is an prosepctive observational study of individuals with gender dysphoria about to commence cross sex hormone therapy. Treatment is not affected by the individuals participation in the study and individuals receive the same treatment regardless of participation in this study. The study involves 5 visits at an Australian urban tertiary hospital Endocrinology Department over 24 months. Baseline: history, physical examination, quality of life questionnaires, bloods, DXA, HRpQCT 3 months: history, physical examination, quality of life questionnaires, bloods 6, 12, 24 months: history, physical examination, quality of life questionnaires, bloods, DXA, HRpQCT

Locations(1)

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

VIC, Australia

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ACTRN12617000584336

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