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Estrogen Supplementation and Bone Health in Women With CF

RecruitingPhase 4Ages 0 Years - 100 YearsFemaleJohns Hopkins University
NCT05704036 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to learn about the role of estrogen and other hormones in bone development in adolescent and young adult women with cystic fibrosis (CF). The study has two main components, an observational study and a feasibility sub-study. The main questions it aims to answer are: * How do different forms of hormonal contraception (e.g. birth control pill or other progesterone only methods) impact bone health? * Is a study of transdermal estradiol (estrogen skin patches) feasible in this group? * How does transdermal estradiol impact bone health and quality of life? Participants in the observational study will have three study visits (baseline, 6 months, and 12 months). At all visits, participants will have blood drawn and will complete questionnaires. At the baseline and 12 month visits, participants will additionally have x-rays and DXAs (bone density assessment). Between

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📋 Eligibility rules (as published)
Observational Study: Inclusion Criteria: * CF Diagnosis * Females who have had at least 1 menstrual cycle * Planning to use same formulation of estrogen supplementation (or none) for duration of study Exclusion Criteria: * Use of anti-osteoporosis therapy including anti-resorptives such as bisphosphonates or anabolic agents such as teriparatide or denosumab * Conditions in which bone loss is known to be present or expected to occur, such as lactation * Pregnant or planning to become pregnant * In the opinion of the CF care team or study investigators participant should not participate in the study * Inability to provide informed consent/assent Feasibility Sub-Study: Inclusion Criteria: * All of above and * \<35 years old * At least 2 years after first menstrual cycle * Symptoms of low estrogen and/or low serum estradiol levels (\< 50 pg/mL) Exclusion Criteria: * All of above and * Contraindications to transdermal estradiol * Current use of systemic estrogen (such as estrogen-containing oral contraceptive pill) * Previous lung or liver transplant * Use of chronic systemic glucocorticoids * Severe vitamin D deficiency (serum 25(OH)D \< 6 ng/mL) * Conditions increasing risk of clot: history of previous deep vein thrombus or pulmonary embolism, current immobility, current peripherally inserted central catheter or mediport, known hypercoagulable condition * Baseline study visit falls between 1 and 8 weeks after initiation of CF transmembrane receptor (CFTR) modulator * Currently in pulmonary exacerbation * Recent antibiotic use within the past 4 weeks for an acute pulmonary exacerbation * Unwilling or unable to use a non-estrogen containing method of contraception such as barrier, abstinence, or progesterone-only method
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What it tests

  • Transdermal estrogen
  • Progesterone
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Where

1 site
Johns Hopkins
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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