NCT05704036 · Johns Hopkins University
Estrogen Supplementation and Bone Health in Women With CF
(STURDY)
What this study 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.
View original scientific description
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.
Interventions
DRUG
Transdermal estrogen
Transdermal estradiol 0.1 mg/day, applied once weekly
DRUG
Progesterone
Progesterone 200 mg daily for 10 days/month, if participant is not on progesterone-containing contraceptive
Primary outcome measures
Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline and 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Collaborators
Cystic Fibrosis Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 14, 2025 · Source of record for eligibility and locations