The Effect on Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population on Bone Density, Fractures, Memory/Cognitive Function and Qualities of Life

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

• On stable dose of sex steroid hormonal therapy for at least 6 months prior to enrolling

• Must be living in the Washington, D.C. area for at least 12 months following enrollment

Locations
United States
Maryland
Walter Reed National Military Medical Center
RECRUITING
Bethesda
Contact Information
Primary
CAPT Than D Hoang, D.O., MC, USN
thanh.d.hoang.mil@health.mil
301-295-5165
Backup
Iris E Morris, BA
iris.e.morris3.civ@health.mil
301-319-4599
Time Frame
Start Date: 2021-03-09
Estimated Completion Date: 2025-08
Participants
Target number of participants: 75
Treatments
Primary/Secondary Untreated Hypogonadism
Subjects in group 1 will take clinically indicated testosterone replacement therapy (Fortesta-injection, gel and transdermal) for 12 months with titration for a serum total T level between 300-600 ng/dL.
Male-to-Female (MTF)
Subjects in group 2 will take clinically indicated estrogen therapy (Estradiol-orally and transdermal and/or spironolactone-orally) for 12 months for hormonal transition period.
Female-to-Male (FTM)
Subjects in group 3 will take clinically indicated testoserone replacement therapy (Fortesta-injection, gel and transdermal) for 12 months for hormonal transition period.
Sponsors
Leads: Walter Reed National Military Medical Center

This content was sourced from clinicaltrials.gov