Boston, MANCT06533865Now EnrollingIRB Ready

Functional Hypothalamic Amenorrhea Clinical Trial in Boston, MA

Access cutting-edge functional hypothalamic amenorrhea treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Massachusetts General Hospital

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Expert Care in Boston

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related functional hypothalamic amenorrhea treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Functional Hypothalamic Amenorrhea Study in Boston

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

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion Criteria

For FHA and controls:
Female, age 14-30 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
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 inclusion criteria for FHA:
Less than 3 menses in the preceding 6 months
BMD Z-score ≤ -1.0 at ≥ 1 skeletal site (for subjects \<18 years old, we wi

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06533865) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Functional Hypothalamic Amenorrhea Treatment Options in Boston, MA

If you're searching for functional hypothalamic amenorrhea treatment options in Boston, MA, this clinical trial (NCT06533865) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced functional hypothalamic amenorrhea specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all functional hypothalamic amenorrhea clinical trials near you to find additional studies recruiting in your area.

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