NCT05704036 Estrogen Supplementation and Bone Health in Women With CF
| NCT ID | NCT05704036 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Johns Hopkins University |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 75 participants in total. It began in 2023-05-02 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 visits, participants will complete brief questionnaires. Researchers will compare various measurements over time to assess the impact of different forms of hormonal contraception. Participants in the feasibility sub-study will apply transdermal estradiol patches once weekly for 12 months, fill out brief quality-of-life surveys in between study visits, and complete blood draws and questionnaires at four study visits (baseline, 3 months, 6 months, and 12 months). The participants will also have x-rays and DXAs performed at the baseline and 12 month visits. Researchers will examine changes in various measurements to determine the impact of transdermal estradiol.
Eligibility Criteria
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
Contact & Investigator
Malinda Wu, MD, MSc
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05704036 clinical trial?
This trial is open to female participants only, aged 0 Years or older, up to 100 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05704036 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05704036 currently recruiting?
Yes, NCT05704036 is actively recruiting participants. Contact the research team at cwang202@jh.edu for enrollment information.
Where is the NCT05704036 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05704036 clinical trial?
NCT05704036 is sponsored by Johns Hopkins University. The principal investigator is Malinda Wu, MD, MSc at Johns Hopkins University. The trial plans to enroll 75 participants.