Condition: FHA (Functional Hypothalamic Amenorrhea) · Sponsor: Massachusetts General Hospital
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).
This description comes directly from the study's public registry record.
Karen K Miller, MD · 617-726-3870 · kkmiller@mgh.harvard.edu
Melanie Haines, MD · 617-726-3897 · mshaines@mgh.harvard.edu
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| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| University of Virginia Medical Center | Charlottesville, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06533865