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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06533865
Phase
PHASE3
Status
Recruiting
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Conditions

  • FHA (Functional Hypothalamic Amenorrhea)

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Romosozumab — DRUG
    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.
  • Placebo — DRUG
    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.
  • Zoledronic acid — DRUG
    One intravenous infusion

Study Details

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).

Key Dates

Start date
Mar 19, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Romosozumab
    Participants with functional hypothalamic amenorrhea randomized to romosozumab.
  • Placebo Comparator: Placebo
    Participants with functional hypothalamic amenorrhea randomized to placebo.
  • No Intervention: Healthy Controls
    Healthy controls (girls and women with regular menstrual periods)

Primary Outcome Measure

Lumbar spine bone density [ Time Frame: 0 and 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Karen Miller, MD
[email protected]
617-726-3870
Melanie Haines, MD
[email protected]
617-726-3897
Karen Miller, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Medical CenterCharlottesvilleVirginia22903
Madhusmita Misra, MD, MPH
[email protected]
434-924-9141
Andrea Marrs, MS
[email protected]
434-982-0871
Madhusmita Misra, MD, MPH (PRINCIPAL_INVESTIGATOR)

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