Healthy transgender persons (the effect of differences in sex hormones on the amount of bone marrow fat)
Conditions
Interventions
Trade Name: Anastrozole
Product Name: Anastrozole
Product Code: RVG 106400
Pharmaceutical Form: Film-coated tablet
Trade Name: Decapeptyl
Product Name: Triptorelin
Pharmaceutical Form: Powder and sol
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous use of cross-sex hormones • Contraindications to MRI scanning as determined by the standard VUmc checklist (See F4. Checklist MRI) • Use of bone-modifying or adipose tissue-modifying drugs, current or in history o Bisphosphonates (alendronic acid, clodronic acid, ibandronic acid, pamidronic acid, risedronic acid, zoledronic acid, etidronate) o Estrogen receptor modulators (raloxifene, bazedoxifene) o Calcium regulating agents (denosumab, calcitonin, teriparatide, strontium ranelate, cinacalcet, etelcalcetine) o Corticosteroids ( • Bone or bone marrow diseases, current or in history o Metabolic (osteroporosis, osteomalacia, dystosis, osteodystrophia, Pagets disease, osteogenesis imperfecta) o Malignancy (primary, metastatic) o Infectious (osteomyelitis, periostitis) o Mechanic (lumbal vertebral fracture) • Bone marrow diseases (leukemia, myelodysplastic syndrome, myeloproliferative disorders) • Platelet count <120*109/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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of sex hormones on bone marrow fat fat;Secondary Objective: To determine the effect of sex hormones on visceral and liver fat. And to test whether DXA can be used to calculate the amount of visceral fat in transgender patients and if so, what algorithm to use.;Primary end point(s): The main study parameter is the change in vertebral bone marrow fat fraction, measured by MRI quantitative chemical shift imaging (QCSI);Timepoint(s) of evaluation of this end point: Baseline (before start of hormones), week 6 (after start GnRH analogues), week 8 (after start cross-sex hormones), week 18, week 58 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes in visceral and liver fat in cm2, measured by MRI and DXA - Bone mineral density in g/cm2, measured by DXA - Bone turnover markers (Ctx, P1NP, osteocalcin) - Leptin and adiponectine level - Inflammation markers (e.g. IL-6, HsCRP, G-CSF) - Platelet activation (e.g. PFA-200 paremeters, plasma thromboxane B2, flow-cytometry);Timepoint(s) of evaluation of this end point: Baseline (before start of hormones), week 6 (after start GnRH analogues), week 8 (after start cross-sex hormones), week 18, week 58 | — |
Countries
Netherlands
Contacts
Public ContactH. Bisschop
VU University Medical Center
Outcome results
None listed