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NCT06533865 · ClinicalTrials.gov registry record · Phase 3
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
A Phase 3 study of FHA (Functional Hypothalamic Amenorrhea), sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
- 2
- Study locations
NCT06533865: Recruiting Phase 3 study of FHA (Functional Hypothalamic Amenorrhea), sponsored by Massachusetts General Hospital.
NCT06533865 is a Phase 3 study of FHA (Functional Hypothalamic Amenorrhea) that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 114 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06533865, a Phase 3 study of FHA (Functional Hypothalamic Amenorrhea), is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
6-month change in lumbar spine bone density
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Romosozumab
- DRUG Zoledronic acid
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
Virginia
- University of Virginia Medical Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2025-03-19 |
| Est. Completion | 2029-04 |
| Phase | Phase 3 |
What NCT06533865 shows while recruiting
NCT06533865 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with FHA (Functional Hypothalamic Amenorrhea) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06533865 reports a single indexed study location in Massachusetts, Virginia.
Frequently Asked Questions
What is clinical trial NCT06533865 about?
NCT06533865 is a clinical study titled "Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea". 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...
What is the current status of trial NCT06533865?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2025-03-19. Estimated completion is 2029-04.
What conditions does trial NCT06533865 study?
This clinical trial studies the following conditions: FHA (Functional Hypothalamic Amenorrhea).
What interventions are being tested in trial NCT06533865?
The interventions under investigation include: Placebo (DRUG), Romosozumab (DRUG), Zoledronic acid (DRUG).
Who is sponsoring clinical trial NCT06533865?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06533865 being conducted?
This trial has 2 study locations across Massachusetts, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for FHA (Functional Hypothalamic Amenorrhea)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06533865's enrollment target sits among peer trials
114 1649th of 2000 higher than 350 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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