EUCTR2017-003072-31-NL进行中（未招募）1 期
The effects of sex hormone administration on marrow and visceral adiposity - SHAMVA
VU University Medical Center0 个研究点目标入组 40 人开始时间: 2018年3月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •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)
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