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Trial registered on ANZCTR


Trial ID
ACTRN12617000584336
Ethics application status
Approved
Date submitted
12/04/2017
Date registered
26/04/2017
Date last updated
8/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of cross-sex hormone therapy on bone microarchitecture in transgender
individuals
Scientific title
The effects of cross-sex hormone therapy on bone microarchitecture in transgender
individuals. A prospective controlled observational study.
Secondary ID [1] 291680 0
Nil known
Universal Trial Number (UTN)
U1111-1195-4107
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone health 302843 0
Body composition 302844 0
Transgender 302846 0
Condition category
Condition code
Metabolic and Endocrine 302328 302328 0 0
Metabolic disorders
Musculoskeletal 302383 302383 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Intervention code [1] 297766 0
Not applicable
Comparator / control treatment
Female and male controls will be recruited and undergo the same study visit schedule as described above. Controls may not have a diagnosis of gender dysphoria and must not be receiving treatment with cross sex hormones, anti-androgens or other agents that may affect bone health.
Control group
Active

Outcomes
Primary outcome [1] 301742 0
Changes in bone microarchitecture as measured by HR-pqCT
Timepoint [1] 301742 0
0,6, 12, 24 months
Secondary outcome [1] 333743 0
Serum bone remodeling markers (CTX and P1NP)
Timepoint [1] 333743 0
0, 3, 6, 12, 24 months
Secondary outcome [2] 333744 0
Abdominal fat volume as measure by DXA
Timepoint [2] 333744 0
0, 6, 12, 24 months
Secondary outcome [3] 333745 0
Lean body mass as measure by DXA
Timepoint [3] 333745 0
0, 6, 12, 24 months
Secondary outcome [4] 333746 0
Homeostatic model assessment of insulin resistance (HOMA-IR) calculated from serum
glucose, insulin and c-paptide levels.
Timepoint [4] 333746 0
0, 3, 6, 12, 24 months
Secondary outcome [5] 333747 0
Serum fasting lipid levels
Timepoint [5] 333747 0
0, 3, 6, 12, 24 months
Secondary outcome [6] 333748 0
Quality of life as assessed using validated questionnaires (SF-36 Quality of Life Questionnaire and Gender Preoccupation and Stability Questionnaire (GPSQ)).
Timepoint [6] 333748 0
0, 3, 6, 12, 24 months
Secondary outcome [7] 333870 0
Areal bone mineral density (lumbar spine) as measured by DXA
Timepoint [7] 333870 0
0,6,12,24 months
Secondary outcome [8] 333871 0
Areal bone mineral density (femoral neck) as measured by DXA
Timepoint [8] 333871 0
0, 6, 12 24 months
Secondary outcome [9] 333873 0
Areal bone mineral density ( non-dominant
radius) as measured by DXA
Timepoint [9] 333873 0
0, 6, 12, 24 months

Eligibility
Key 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

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Generalized linear mixed model for longitudinal analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7830 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 15767 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 15768 0
3084 - Heidelberg
Recruitment postcode(s) [3] 15769 0
3081 - Heidelberg Heights

Funding & Sponsors
Funding source category [1] 296177 0
Charities/Societies/Foundations
Name [1] 296177 0
Austin Health Medical Research Foundation
Address [1] 296177 0
Austin Health
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 296177 0
Australia
Funding source category [2] 296178 0
Charities/Societies/Foundations
Name [2] 296178 0
True Colours Research Foundation
Address [2] 296178 0
Austin Health, Heidelberg Repatriation Hospital
300 Waterfall road
Heidelberg West,
Victoria, 3081
Country [2] 296178 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
VIC 3084
Country
Australia
Secondary sponsor category [1] 295087 0
University
Name [1] 295087 0
University of Melbourne
Address [1] 295087 0
The University of Melbourne
Victoria 3010
Country [1] 295087 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297423 0
Austin Health HREC
Ethics committee address [1] 297423 0
Office for Research
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria 3084
Ethics committee country [1] 297423 0
Australia
Date submitted for ethics approval [1] 297423 0
03/02/2017
Approval date [1] 297423 0
31/03/2017
Ethics approval number [1] 297423 0
HREC17Austin74

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73990 0
Prof Jeffrey Zajac
Address 73990 0
Level: 02 Room: 2.51,
Melbourne Brain Centre (Austin),
Austin Hospital- 145 Studley Road
Heidelberg,
Victoria 3084
Country 73990 0
Australia
Phone 73990 0
+61 3 9496 5000
Fax 73990 0
Email 73990 0
j.zajac@unimelb.edu.au
Contact person for public queries
Name 73991 0
Dr Ingrid Bretherton
Address 73991 0
Repatriation Hospital (Austin Health)
300 Waterdale Road
Heidelberg West
Victoria 3081
Country 73991 0
Australia
Phone 73991 0
+ 61 3 9496 2486
Fax 73991 0
Email 73991 0
ibretherton@student.unimelb.edu.au
Contact person for scientific queries
Name 73992 0
Dr Ingrid Bretherton
Address 73992 0
Repatriation Hospital (Austin Health)
300 Waterdale Road
Heidelberg West
Victoria 3081
Country 73992 0
Australia
Phone 73992 0
+ 61 3 9496 2486
Fax 73992 0
Email 73992 0
ibretherton@student.unimelb.edu.au