Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults With Functional Hypothalamic Amenorrhea
Massachusetts General Hospital
Summary
The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation of the menstrual period due to intense exercise, stress, or an eating disorder) who have low bone density. Participants will be randomly assigned to receive romosozumab or placebo for 6 months. All participants will receive one IV infusion of zoledronate at the 6 month visit. All participants will also receive transdermal estradiol and cyclic progesterone. We will investigate whether participants who receive active romosozumab will demonstrate greater improvements in bone density at one year than those who receive placebo. We will also compare bone density over a year with healthy controls (girls and women of similar age who have regular menstrual periods).
Eligibility
- Age range
- 14–30 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: For FHA and controls: * Female, age 14-30 years, skeletally mature with bone age ≥ 12 years * For women of reproductive age, agree to use one of the following for the study duration: 1. an effective non-hormonal contraceptive method 2. a progestin releasing intrauterine device (no evidence of systemic skeletal effects) 3. a progestin releasing implant 4. does not have a history of sexual activity that could lead to pregnancy (i.e., same-sex partners only or total abstinence has been and is their preferred lifestyle) * Biochemical criteria: * Negative βHCG (pregna…