The effects of sex hormone administration on bone marrow and visceral fat

Phase 1

• Conditions: Healthy transgender persons (the effect of differences in sex hormoneson the amount of bone marrow fat); Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-003072-31-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-12
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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
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

•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
oBisphosphonates (alendronic acid, clodronic acid, ibandronic acid, pamidronic acid, risedronic acid, zoledronic acid, etidronate)
oEstrogen receptor modulators (raloxifene, bazedoxifene)
oCalcium regulating agents (denosumab, calcitonin, teriparatide, strontium ranelate, cinacalcet, etelcalcetine)
oCorticosteroids (
•Bone or bone marrow diseases, current or in history
oMetabolic (osteroporosis, osteomalacia, dystosis, osteodystrophia, Pagets disease, osteogenesis imperfecta)
oMalignancy (primary, metastatic)
oInfectious (osteomyelitis, periostitis)
oMechanic (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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified