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The effects of sex hormone administration on marrow and visceral adiposity

The effects of sex hormone administration on marrow and visceral adiposity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25190
Enrollment
40
Registered
2019-02-11
Start date
2019-02-14
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No diseases are being studied. Amount of bone marrow and visceral fat, thrombocyte function.

Interventions

Transwomen will receive a GnRH analogue every 4 weeks from week 0 until week 20 and estradiol from week 6 and cyproterone acetate from week 20 until the end of the study (week 58). Transmen will recei

Sponsors

Amsterdam UMC, location VUmc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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)

Design outcomes

Primary

MeasureTime frame
Changes in vertebral marrow fat fraction measured by MRI quantitative chemical shift imaging (QCSI), changes in visceral fat, measured by MRI and DXA.

Secondary

MeasureTime frame
? Bone turnover markers (Ctx, P1NP, osteocalcin) ? Adiponectin and leptin. ? Changes in inflammation markers (HsCRP, IL-6, G-CSF) ? 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

Contacts

Public ContactMarieke Tebbens

Amsterdam UMC, location VUmc

m.tebbens@vumc.nl020-4440322

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)