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New treatment option for FHA (Functional Hypothalamic Amenorrhea)
Official title Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
ClinicalTrials.gov ID: NCT06533865
What this study is testing
What is Romosozumab?
Romosozumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for fha (functional hypothalamic amenorrhea).
Also referred to as Evenity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 30, women only
You may be able to join if
- For FHA and controls:
- Female, age 14-30 years, skeletally mature with bone age ≥ 12 years
- For women of reproductive age, agree to use one of the following for the study duration:
- an effective non-hormonal contraceptive method
- a progestin releasing intrauterine device (no evidence of systemic skeletal effects)
You likely can't join if
- For FHA and controls
- Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus
- Use of bisphosphonates in the past year
- Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation).
- Current use of systemic corticosteroids
- Migraine with aura as classified in IHS Classification ICHD-3.
See the full eligibility criteria
- For FHA and controls:
- Female, age 14-30 years, skeletally mature with bone age ≥ 12 years
- For women of reproductive age, agree to use one of the following for the study duration:
- an effective non-hormonal contraceptive method
- a progestin releasing intrauterine device (no evidence of systemic skeletal effects)
- a progestin releasing implant
- does not have a history of sexual activity that could lead to pregnancy (i.e., same-sex partners only or total abstinence has been and is their preferred lifestyle)
- Biochemical criteria:
- Negative βHCG (pregnancy test)
- TSH within twice the upper limit of normal; potassium, magnesium within the normal range; prolactin \<10 ng/mL above the upper limit of normal; FSH not elevated.
- Serum ALT ≤ 3 times upper limit of normal, LDL ≤ 190 mg/dl
- eGFR ≥ 30ml/minute
- If the diagnosis of FHA is unclear, we may check additional labs (e.g., testosterone and sex hormone binding globulin if there is a suspicion of PCOS based on clinical hyperandrogenism). Additional for FHA:
- Less than 3 menses in the preceding 6 months
- BMD Z-score ≤ -1.0 at ≥ 1 skeletal site (for people \<18 years old, we will use the height Z-score-adjusted BMD Z-score using the pediatric bone density calculator developed by the National Institutes of Health and...
- Dental check-up within the past year
- If the menstrual status of the subject is unclear due to the presence of a progestin-releasing IUD, serum estradiol levels will be checked twice, at least one week apart. Both estradiol levels must be \< 50 pg/mL.At the...
- For FHA and controls
- Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus
- Use of bisphosphonates in the past year
- Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation).
- Current use of systemic corticosteroids
- Migraine with aura as classified in IHS Classification ICHD-3.
- Personal history of or first-degree relative with unprovoked thromboembolism (unless the subject has been tested and ruled out for a hypercoagulable state).
- Active substance use disorder; currently smokes or vapes
- 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 FHA
- Cardiovascular: History of 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, primary ovarian insufficiency. A participant with PCOS may be included if a study clinician determines that missed menstrual periods are more likely a...
- 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...
- Planned invasive dental procedure or other planned major surgery for 18 months after the baseline visit
- 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...
- Concerning EKG findings for ischemia Additional exclusion criteria for normal-weight healthy controls
- BMD Z-score \<-2.5 (who we will refer for evaluation)
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.