The effects of sex hormone administration on marrow and visceral adiposity

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Diagnosed with gender dysphoria according to DSM V (transmen or
transwomen)
- Age between 18 and 50 years
- Transmen need to be premenopausal
- Starting cross-sex hormone treatment

Exclusion Criteria

- Previous use of cross-sex hormones
- Use of hormonal contraceptives (exception for Mirena sipral)
- Contraindications to MRI scanning as determined by the standard AMC checklist
- Use of bone-modifying or adipose tissue-modifying drugs, current or in history
- Bisphosphonates (alendronic acid, clodronic acid, ibandronic acid, pamidronic
acid, risedronic acid, zoledronic acid, etidronate)
- Estrogen receptor modulators (raloxifene, bazedoxifene)
- Calcium regulating agents (e.g. denosumab, calcitonin, teriparatide,
strontium ranelate, cinacalcet, etelcalcetine)
- Corticosteroids
- Bone or bone marrow diseases, current or in history
- Metabolic (osteroporosis, osteomalacia, dystosis, osteodystrophia, Pagets
disease, osteogenesis imperfecta)
- Malignancy (primary, metastatic)
- Infectious (osteomyelitis, periostitis), Mechanic (lumbal vertebral
fracture), Bone marrow diseases (leukemia, myelodysplastic syndrome,
myeloproliferative disorders)
- Platelet count <120*10^9/l
- History of non-traumatic major bleeding
- Known bleeding diathesis
- Conditions which require antiplatelet therapy
- Usage of antiplatelet therapy
- Chronic usage of medication known to influence platelet function (e.g.
DOAC*s, NSAIDs, warfarin)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in vertebral bone marrow fat fraction,<br /><br>measured by MRI quantitative chemical shift imaging (QCSI). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are changes in visceral fat in cm2, measured by MRI and<br /><br>DXA; bone mineral density in g/cm2, measured by DXA, bone turnover markers<br /><br>(Ctx, P1NP, osteocalcin) and leptin. Furthermore, we will asses changes in<br /><br>inflammation markers, measured by * amongst others- HsCRP, IL-6, G-CSF. And,<br /><br>lastly, the assesment of changes in platelet activation, measured by PFA<br /><br>Closure Time, PFA Total Volume, PFA Initial Flow Rate, Plasma Thromboxane B2,<br /><br>Flow-cytometry among which p-selectin</p><br>