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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 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. The trial reports 2 study locations across 2 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06533865
The ClinicalTrials.gov registry entry for NCT06533865 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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