NCT06533865View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

March 19, 2025

Primary Completion Date

October 31, 2028

Study Completion Date

April 30, 2029

Conditions
FHA (Functional Hypothalamic Amenorrhea)
Interventions
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

Trial Locations (2)

22903

RECRUITING

University of Virginia Medical Center, Charlottesville

02114

RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER