A Study to Assess Transgender Volumetric Bone Density in Cross Sex Hormone Therapy

Overview

About this study

The purpose of this study is to monitor short term changes in bone microarchitecture, with the initiation of cross sex hormone therapy in transgender men and transgender women – during this time, there is a large flux in hormonal status.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult transgender women and men, ≥ 18 years of age. 
  • Diagnosis of gender dysphoria according to DSM-V.
  • Able and willing to provide informed consent.

Exclusion Criteria:

  • Previous use of cross sex hormone therapy:
    • Estrogen;
    • Testosterone;
    • Progesterone;
    • Spironolactone;
    • 5-Alpha Reductase Inhibitor (Finasteride, Dutasteride);
    • Anti-Androgen (such as Leuprolide, Bicalutamide, Cyproterone Acetate).
  • Previous fracture within 12 months of study.
  • Tobacco users.
  • Presence of clinical diagnosis of any of the following:
    • Significant liver or renal disease;
    • Malignancy (including myeloma);
    • Malabsorption (as defined by clinical diagnosis);
    • Hypoparathyroidism;
    • Hyperparathyroidism;
    • Acromegaly;
    • Cushing’s Syndrome;
    • Hypopituitarism;
    • Severe Chronic Obstructive Pulmonary Disease.
  • Heart failure history.
  • Use of medications affecting bone turnover:
    • Oral or systemic glucocorticoids ≥ 3 Months;
    • Anticonvulsant therapy for seizures in past year;
    • Thiazolidinediones;
    • Thyroid Hormone (causing suppression of thyroid stimulating hormone below normal).
  • Use of previous and current bone modulating therapy:
    • Bisphosphonates;
    • Denosumab;
    • Teriparatide;
    • Abloparatide;
    • Selective Estrogen Receptor Modulators;
    • Romosozumab.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sundeep Khosla, M.D.

Closed for enrollment

Contact information:

Arvind Maheshwari M.B.B.S.

Maheshwari.Arvind@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20509060

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