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Estrogen's Role in Bone Strength for Functional Hypothalamic Amenorrhea (FHA)

This study is looking at how different types of estrogen affect bone strength in young women (ages 14-30) with Functional Hypothalamic Amenorrhea (FHA), a condition where periods stop due to stress, exercise, or low body weight. Researchers want to see if natural estrogen (17β-E2) given as a skin patch works better to improve bone strength over one year compared to natural estrogen taken as a pill, or a synthetic estrogen (ethinyl estradiol) given as a birth control patch. The study will measure changes in your bone density and strength at various body sites. The goal is to find the best way to help improve bone health in women with FHA. The current recruitment status for this study is unclear.

Study design
This is an interventional study planning to enroll 150 women. Participants will be assigned to one of three different estrogen treatments.
What's involved
Participants will take estrogen for one year and have their bone density and strength measured at the beginning and after 12 months.
Compensation
Not stated in the trial record.
Follow-up
Bone measurements will be taken at baseline and after 12 months of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07010146

Role of Estrogen on Skeletal Outcomes in FHA

Recruiting
PHASE2Ages 14–30InterventionalTreatment
University of Virginia
~150 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:transdermal 17β-E2 with cyclic progestinoral 17β-E2 with cyclic progestintransdermal EE+LNG

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Areal BMD at the spine, hip and femoral neck as well as spine trabecular bone score from DXA
Measured over Baseline and post-treatment (12 months)
+3 more outcomes measured

Conditions

Bone Strength
Bone Density
FHA (Functional Hypothalamic Amenorrhea)

Explore related trials

Hypothalamic amenorrhea, functional

Where it's being run

2 sites across 1 states
Virginia2

Study leadership

  • Madhusmita Misra, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Madhusmita Misra, MD, MPH
[email protected]
434-924-9141
Email the study team

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Eligibility criteria

Inclusion

Females, age 14-30 years, skeletally mature with bone age ≥ 14 years (only 2% of growth left)
Women of reproductive age: use of an effective non-hormonal contraceptive method or a progestin releasing intrauterine device (no systemic skeletal effects) for study duration if sexually active. Note: Women who receive a progestin implant for contraception after study enrollment will be allowed to continue and will not be excluded from study.
Biochemical criteria: negative βHCG (pregnancy test), TSH within 2x the upper limit of normal, prolactin \<10 ng/mL above upper limit of normal, potassium between 3.0-5.0, ALT ≤3 times upper limit of normal, LDL ≤190 mg/dl.
Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a TSH within 2x the upper limit of normal for at least a month preceding the baseline study visit.
Menstrual criteria: \< 3 menses in the preceding 6 months.

Exclusion

Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus
Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation)
Substance use disorder; current smoker (\>10 cigarettes per day)
Pregnant, planning to become pregnant within 12 months of the end of treatment and/or breastfeeding
Hypertension or use of anti-hypertensive medications
Other conditions causing oligo-amenorrhea such as PCOS, premature ovarian insufficiency
Known sensitivity or absolute contraindication to any component of study medications (high risk thromboembolic disease, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors, acute viral hepatitis, decompensated cirrhosis, undiagnosed abnormal uterine bleeding
BMI ≥ 25 kg/m2 (efficacy of the contraceptive patch being used in the study is lower at higher BMIs)

What this trial measures

  • Areal BMD at the spine, hip and femoral neck as well as spine trabecular bone score from DXABaseline and post-treatment (12 months)

    Using repeated measures analysis, the investigators will compare change in lumbar spine, total hip and femoral neck BMD and trabecular bone score after 12 months of treatment between the transdermal 17β-E2 group and each of the oral 17β-E2 and transdermal EE+LNG groups. BMD and TBS are assessed using DXA. Unit for BMD is g/cm2.

  • 12-month change in volumetric BMD at the radius and tibiaBaseline and post- treatment (12 months)

    Using repeated measures analysis, the investigators will compare change in volumetric BMD at the radius and tibia after 12 months of treatment between the transdermal 17β-E2 group and each of the oral 17β-E2 and transdermal EE+LNG groups. Volumetric BMD is assessed using HRpQCT (mgHA/cm3)

  • 12-month change in cortical thickness at the radius and tibiaBaseline and post- treatment (12 months)

    Using repeated measures analysis, the investigators will compare change in cortical thickness at the radius and tibia after 12 months of treatment between the transdermal 17β-E2 group and each of the oral 17β-E2 and transdermal EE+LNG groups. Cortical thickness is assessed using HRpQCT (mm).

  • 12-month change in failure load at the radius and tibiaBaseline and post- treatment (12 months)

    Using repeated measures analysis, the investigators will compare change in failure load at the radius and tibia after 12 months of treatment between the transdermal 17β-E2 group and each of the oral 17β-E2 and transdermal EE+LNG groups. Failure load is assessed using microfinite element analysis (N).