The effects of sex hormone administration on marrow and visceral adiposity
- Conditions
- o diseases are being studied. Amount of bone marrow and visceral fat, thrombocyte function.
- Registration Number
- NL-OMON25190
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
? Diagnosed with gender dysphoria according to DSM V (female-to-male or male-to-female)
? Age between 18 and 50 years
? Female-to-male transgenders need to be premenopausal
? Starting cross-sex hormone treatment
? Previous use of cross-sex hormones
? Contraindications to MRI scanning
? Participation in other studies (with exception of the ENIGI study)
? Use of bone-modifying or adipose tissue-modifying drugs, current or in history (bisphosphonates, estrogen receptor modulators, calcium regulating agents, corticosteroids)
? Bone or bone marrow diseases, current or in history (metabolic, malignancy, infectious, mechanic, bone marrow diseases)
? 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in vertebral marrow fat fraction measured by MRI quantitative chemical shift imaging (QCSI), changes in visceral fat, measured by MRI and DXA.
- Secondary Outcome Measures
Name Time Method ? Bone turnover markers (Ctx, P1NP, osteocalcin)<br>? Adiponectin and leptin.<br>? Changes in inflammation markers (HsCRP, IL-6, G-CSF)<br>? Changes in platelet activation, measured by PFA Closure Time, PFA Total Volume, PFA Initial Flow Rate, Plasma Thromboxane B2, Flow-cytometry among which p-selectin