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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000584336
Enrollment
75
Registered
2017-04-26
Start date
2017-05-16
Completion date
2019-12-31
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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: his

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

Sponsors

Austin Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Adults ages over 18 years Gender dysphoria using DSM-V criteria About to commence treatment with cross-sex hormone (CSH) therapy Control/comparator group Adults aged over 18 years Not previously on or planning to take cross sex hormone therapy

Exclusion criteria

Any prior CSH therapy or anti-androgen use Any contraindication to CSH or anti-andgrens Prior hypogonadism including previous oophorectomy or orchidectomy Established osteoporosis, metabolic bone disease, glucocorticoid therapy, prior bisphosphonate therapy, pregnancy, thromboembolic disease, liver disease, or any disease likely to lead to impairment in bone health Any serious illness or likelihood of death within the study period Inability to give informed consent or comply with the study protocol requirements Control/ comparator group Any prior CSH therapy or anti-androgen use Any contraindication to CSH or anti-andgrens Prior hypogonadism including previous oophorectomy or orchidectomy Established osteoporosis, metabolic bone disease, glucocorticoid therapy, prior bisphosphonate therapy, pregnancy, thromboembolic disease, liver disease, or any disease likely to lead to impairment in bone health Any serious illness or likelihood of death within the study period Inability to give informed consent or comply with the study protocol requirements

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026