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New treatment option for Bone Strength
Official title Role of Estrogen on Skeletal Outcomes in FHA
ClinicalTrials.gov ID: NCT07010146
What this study is testing
What is transdermal 17β-E2 with cyclic progestin?
transdermal 17β-E2 with cyclic progestin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for bone strength.
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 purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control. Participants will: 1.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- Which group you join is decided by chance.
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
- 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...
- Biochemical criteria: negative βHCG (pregnancy test), TSH within 2x the upper limit of normal, prolactin \<10 ng/mL above upper limit of normal...
- Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a TSH within 2x the upper limit of normal...
- Menstrual criteria: \< 3 menses in the preceding 6 months.
You likely can't join if
- Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus
- Primary thyroid dysfunction will be defined as a TSH level more than 2X the upper limit of normal per given reference range with unknown thyroid...
- Patients with hypothyroidism will be excluded if not appropriately treated with levothyroxine and if they do not have a TSH level within 2X the upper...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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.
- Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus
- Primary thyroid dysfunction will be defined as a TSH level more than 2X the upper limit of normal per given reference range with unknown thyroid antibody status, or an abnormal TSH if known positive antibodies.
- Patients with hypothyroidism will be excluded if not appropriately treated with levothyroxine and if they do not have a TSH level within 2X the upper limit of normal for at least a month preceding the baseline study...
- 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...
- BMI ≥ 25 kg/m2 (how well it works of the contraceptive patch being used in the study is lower at higher BMIs)
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 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.