NCT06533865

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults With Functional Hypothalamic Amenorrhea

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 14 Years – 30 Years
• Healthy volunteers: Not accepted

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).

Conditions

• FHA (Functional Hypothalamic Amenorrhea)

Interventions

Type	Name	Description
DRUG	Romosozumab	Six monthly subcutaneous injections. This group will also receive a 100-microgram transdermal estradiol patch applied twice weekly, and 200 mg of oral progesterone for the first 12 days of each month.
DRUG	Placebo	Identical to romosozumab but inactive. This group will also receive a 100-microgram transdermal estradiol patch applied twice weekly, and 200 mg of oral progesterone for the first 12 days of each month.
DRUG	Zoledronic acid	One intravenous infusion

Timeline

• Start date: 2025-03-19
• Primary completion: 2028-10-01
• Completion: 2029-04-01
• First posted: 2024-08-01
• Last updated: 2026-03-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study