NCT05704036RecruitingPhase 4
Estrogen Supplementation and Bone Health in Women With CF
Estrogen Supplementation and Bone Health in Women With CF (STURDY)
Source: ClinicalTrials.gov · Last updated 14 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 10 Jan 2023
- Start date
- 2 May 2023
- Primary completion date
- Jan 2027
- Lead sponsor
- Johns Hopkins University
- Diseases
- Cystic fibrosis, Osteoporosis
- NCT number
- NCT05704036
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 75
- From 2 May 2023 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of anti-osteoporosis therapy including anti-resorptives such as bisphosphonates or anabolic agents such as teriparatide or denosumab
- Previous lung or liver transplant
- 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
Other illness
- Conditions in which bone loss is known to be present or expected to occur, such as lactation
Lab values
- Severe vitamin D deficiency (serum 25(OH)D \< 6 ng/mL)
Other
- 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:
- All of above and
- Contraindications to transdermal estradiol
- Current use of systemic estrogen (such as estrogen-containing oral contraceptive pill)
- Use of chronic systemic glucocorticoids
- 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
Who the study is looking for
- 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
- 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)
Criteria the registry did not label
- Observational Study:
Age in the registry: 0 years to 100 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.