Actively Recruiting
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
Led by Massachusetts General Hospital · Updated on 2026-04-23
114
Participants Needed
2
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 14 to 30 years, skeletally mature with bone age at least 12 years
- For women of reproductive age, agreement to use effective non-hormonal contraception, progestin-releasing intrauterine device, progestin implant, or have no history of pregnancy risk
- Negative pregnancy test (beta HCG)
- Normal thyroid stimulating hormone, potassium, magnesium, prolactin, and follicle stimulating hormone levels within specified limits
- Liver enzymes and LDL cholesterol within safe ranges
- Estimated glomerular filtration rate at least 30 ml/minute
- If FHA diagnosis unclear, additional hormone tests may be done
- For FHA participants: fewer than 3 menstrual periods in the past 6 months
- Bone mineral density Z-score less than or equal to -1.0 at one or more skeletal sites
- Dental check-up within the past year
- If menstrual status unclear due to progestin IUD, low estradiol levels confirmed twice
- For PCOS diagnosis, estradiol levels must be below 50 pg/mL
You will not qualify if you...
- Diseases affecting bone other than FHA such as untreated thyroid problems, Cushing's disease, kidney failure, diabetes
- Use of bisphosphonates in the past year
- Use of medications affecting bone metabolism within 3 months (except calcium and vitamin D)
- Current use of systemic corticosteroids
- Migraine with aura
- Personal or first-degree family history of unprovoked blood clots unless tested and cleared
- Active substance use disorder, current smoking or vaping
- History of cancer or Paget disease of bone
- Pregnant, planning pregnancy within 12 months after treatment, or breastfeeding
- History of heart attack, stroke, hypertension, or use of blood pressure medications
- Immunodeficiency or immunosuppressive therapy
- Other causes of oligo-amenorrhea like primary ovarian insufficiency; PCOS allowed if FHA likely cause
- Osteonecrosis of the jaw or risk factors such as recent dental surgery or poor oral health
- Planned major surgery or invasive dental procedure within 18 months after baseline
- Known allergy or contraindication to study medications or supplements
- Abnormal ECG findings indicating ischemia
- For healthy controls, bone density Z-score below -2.5
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Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
K
Karen K Miller, MD
CONTACT
M
Melanie Haines, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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