Actively Recruiting
Estrogen Supplementation and Bone Health in Women With CF
Led by Johns Hopkins University · Updated on 2025-11-14
75
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Estrogen Supplementation and Bone Health in Women With CF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of cystic fibrosis
- Female who has had at least one menstrual cycle
- Planning to use the same form of estrogen supplementation or none throughout the study
- For feasibility sub-study: under 35 years old
- For feasibility sub-study: at least 2 years after first menstrual cycle
- For feasibility sub-study: symptoms of low estrogen and/or low serum estradiol levels (< 50 pg/mL)
You will not qualify if you...
- Use of anti-osteoporosis therapy such as bisphosphonates, teriparatide, or denosumab
- Conditions causing or expected to cause bone loss, such as lactation
- Pregnant or planning to become pregnant
- Investigator or CF care team advises against participation
- Unable to provide informed consent or assent
- For feasibility sub-study: contraindications to transdermal estradiol
- For feasibility sub-study: current use of systemic estrogen like estrogen-containing oral contraceptives
- For feasibility sub-study: previous lung or liver transplant
- For feasibility sub-study: use of chronic systemic glucocorticoids
- For feasibility sub-study: severe vitamin D deficiency (serum 25(OH)D < 6 ng/mL)
- For feasibility sub-study: increased clot risk such as history of deep vein thrombosis or pulmonary embolism, current immobility, current peripherally inserted central catheter or mediport, or known hypercoagulable condition
- For feasibility sub-study: baseline visit between 1 and 8 weeks after starting CFTR modulator
- For feasibility sub-study: currently experiencing pulmonary exacerbation
- For feasibility sub-study: recent antibiotic use within past 4 weeks for acute pulmonary exacerbation
- For feasibility sub-study: unwilling or unable to use non-estrogen contraception methods like barrier, abstinence, or progesterone-only methods
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Cynthia Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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