It has been known that both estrogen and testosterone are the major sex steroids regulating bone metabolism and other physiological changes in both male and female, respectively. In postmenopausal women, osteoporosis is a major concern secondary to the lack of estrogen. These patients also experience a number of physiological changes that affect their life permanently to include hot flashes, irritability, difficulty concentrating, depression and mental confusion. In hypogonadal men, testosterone deficiency could lead to higher prevalence of depression, osteoporosis, fracture and frailty. Given the new military policy starting to support treatment for gender identity dysphoria military personnel, the number of transgender patients in our Endocrinology clinic has been slowly increasing over the past several months. These patients will require either testosterone replacement therapy or estrogen therapy to achieve their desired sexual characteristics. However, as mentioned above, the lack of estrogen or testosterone in female and male, respectively, could cause several issue in their body composition, cognitive function and quality of life. We designed this prospective case-control study to include patients with hypogonadism and the transgendered populations to learn about the long-term effects of these hormonal replacement therapies on bone density, fractures, memory/cognitive function and quality of life. This is a repetitive measures study taken at baseline, 6-months, and 12-months for three groups consisting of at least 75 subjects. The study will involve 3 arms, i.e. Group 1 primary/secondary untreated hypogonadism, Group 2 male-to female (MTF), and Group 3 female-to-male (FTM) participants that are planning to start hormone replacement therapy as per standard clinical guidelines.
Male and female DoD health care beneficiaries
Ages 18-65
Diagnosed with primary hypogonadism or transgender treatment for at least 6 months
Under care for gender identity dysphoria
Pregnancy, plan for pregnancy in the next 12 months
Cardiac disease, especially coronary artery disease
Malabsorption disorder
Gastrointestinal surgeries
The study findings will be generalized to patients ages of 18 to 65 who are planning to be placed on sex steroid hormone either for hypogonadism or transgender treatment as per clinical guidelines.
Case-control
Prospective
Fortesta
DrugPrimary/secondary untreated hypogonadism patients receive Fortesta injection, gel and transdermal treatment for 12 months with titration for a serum total T level between 300-600ng/dL.
Estradiol
DrugMale-to-female (MTF) receive Estradiol orally and transdermal and/or spironolactone-orally) treatment for 12 months for hormonal transition period.
Fortesta
DrugFemale-to-male (FTM) receive Fortesta injection, gel and transdermal treatment for 12 months for hormonal transition period.
Effects of sex steroid hormone replacement therapy on body composition
Subjects will undergo Dual energy X-ray Absorptiometry conducted by the research coordinator assessing bone density, body composition, and risk of fractures.
Effects of sex steroid hormone replacement therapy in treating hypogonadism and in transgender patients using Dual energy X-ray Absorptiometry assessing body composition and Bone Mineral Density
We designed this prospective case-control study to include patients with hypogonadism and the transgendered populations to learn about the long-term effects of these hormonal replacement therapies on bone density, fractures, memory/cognitive function and quality of life. This is a repetitive measures study taken at baseline, 6-months, and 12-months for three groups consisting of at least 75 subjects. The study will involve 3 arms, i.e. Group 1 primary/secondary untreated hypogonadism, Group 2 male-to female (MTF), and Group 3 female-to-male (FTM) participants that are planning to start hormone replacement therapy as per standard clinical guidelines.
Examination and comparison of the general health questionnaire among the three study groups
Subjects will undergo a quality of life general health assessment conducted by study investigators
Examination and comparison of the Beck Depression Inventory (a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations) among the three study groups
Subjects will undergo the Beck Depression Inventory conducted by study investigators. Scores of 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. Some items on the BDI have more than one statement marked with the same score.
Examination and comparison of the Wechsler Memory Scale (a comprehensive tool for assessing verbal, visual, working, and recognition memory)
Subjects will undergo the Wechsler memory scale conducted by study investigators. The Wechsler Memory Scale is an individually administered battery designed to assess various memory and working memory abilities of individuals (e.g. auditory memory, visual memory, visual working memory, immediate memory, delayed memory.
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