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NCT06533865 | NOT YET RECRUITING | FHA (Functional Hypothalamic Amenorrhea)

Romosozumab As an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
Sponsor:

Massachusetts General Hospital

Information provided by (Responsible Party):

Karen Klahr Miller, MD

Brief 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).

Condition or disease

FHA (Functional Hypothalamic Amenorrhea)

Intervention/treatment

Romosozumab

Placebo

Zoledronic acid

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 114 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Romosozumab As an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults with Functional Hypothalamic Amenorrhea
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2028-12-01
Estimated Study Completion Date : 2029-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 14 Years to 25 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • For functional hypothalamic amenorrhea and controls
    • * Female, age 14-25 years, skeletally mature with bone age ≥ 14 years (only 2% of growth left)
    • * For women of reproductive age, agree to use an effective non-hormonal contraceptive method or a progestin releasing intrauterine device (no evidence of systemic skeletal effects) for the study duration
    • * Negative βHCG (pregnancy test)
    • * TSH, prolactin, potassium, magnesium within the normal range
    • * Serum ALT ≤ 3 times upper limit of normal, LDL ≤ 190 mg/dl
    • * eGFR ≥ 30ml/minute
    • Additional inclusion criteria for functional hypothalamic amenorrhea
      • * Less than 3 menses in the preceding 6 months
      • * BMD Z-score \< -1.0 at ≥ 1 skeletal site
      • * Dental check-up within the past year
      Exclusion Criteria
      • For functional hypothalamic amenorrhea and controls
      • * Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus
      • * Use of bisphosphonates
      • * Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation).
      • * Substance abuse disorder; current smoker
      • * History of malignancy or Paget disease of bone
      • * Pregnant, planning to become pregnant within 12 months after the end of treatment and/or breastfeeding
      • Additional exclusion criteria for functional hypothalamic amenorrhea
      • * Cardiovascular: Myocardial infarction or stroke; history of hypertension or use of anti-hypertensive medications
      • * Immunodeficiency or taking immunosuppressive therapy
      • * Other conditions that can cause oligo-amenorrhea such as PCOS, premature ovarian insufficiency
      • * Dental: Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental procedures (tooth extraction, dental implants, oral surgery in the past 3 months), poor oral hygiene, periodontal and/or pre-existing dental disease, and current use of corticosteroids
      • * Planned invasive dental procedure over the next 12 months (the duration of the study)
      • * Known sensitivity or absolute contraindication to any of the products or components of the medications to be administered (romosozumab, zoledronic acid, transdermal estradiol, micronized progesterone, calcium or vitamin D supplements)
      • Additional exclusion criteria for normal-weight healthy controls
      • • BMD Z-score \<-2.5 (who we will refer for evaluation)
Romosozumab As an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea

Location Details

NCT06533865

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