NCT06533865 Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
| NCT ID | NCT06533865 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Massachusetts General Hospital |
| Condition | FHA (Functional Hypothalamic Amenorrhea) |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2028-10 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 Criteria
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 (pregnancy test) * TSH within twice the upper limit of normal; potassium, magnesium within the normal range; prolactin \<10 ng/mL above the upper limit of normal; FSH not elevated. * Serum ALT ≤ 3 times upper limit of normal, LDL ≤ 190 mg/dl * eGFR ≥ 30ml/minute * If the diagnosis of FHA is unclear, we may check additional labs (e.g., testosterone and sex hormone binding globulin if there is a suspicion of PCOS bas