Cystic FibrosisPhase 4STURDYNCT05704036
Estrogen Supplementation and Bone Health in Women With CF
A Phase 4 study testing Transdermal estrogen and Progesterone in people with Cystic Fibrosis and Hypoestrogenism, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 100 years, women only
- Conditions the study is for
- Cystic Fibrosis, Hypoestrogenism
- What is being tested?
- Transdermal estrogen and Progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21287
Cynthia Wang, 410-929-3056, cwang202@jh.edu
Malinda Wu, MD, MSc
About this study
Official title: Estrogen Supplementation and Bone Health in Women With CF (STURDY)
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?
Read more
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
- Cystic Fibrosis, Hypoestrogenism
- Being tested
- Transdermal estrogen, Progesterone
- Keywords
- Bone Mineral Density, Osteoporosis, Young Adult, Adolescent, Premenopause, Estradiol, Bone Disease, Bone Diseases, Metabolic, Hormones, Quality of Life
- Medical subject headings
- Cystic Fibrosis, Osteoporosis, Bone Diseases, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal estrogenDrug
Also called Transdermal estradiol, Climara
Transdermal estradiol 0.1 mg/day, applied once weekly
ProgesteroneDrug
Also called Prometrium
Progesterone 200 mg daily for 10 days/month, if participant is not on progesterone-containing contraceptive
| Study group | Role | What they receive |
|---|---|---|
| Observational Study | No intervention | Participants will complete three study visits (baseline, 6 months, and 12 months) involving DXAs (bone density assessment), x-rays, blood draws, and questionnaires. |
| Transdermal Estradiol/Cyclic Progesterone | Experimental | Participants will apply transdermal estradiol patches (0.1 mg/day) weekly for 12 months following baseline study visits. Participants not already using a progesterone-containing contraceptive will also take progesterone (200 mg) for 10 days per month. Receives: Drug: Transdermal estrogen; Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA)
Measured: Baseline and 12 months
Secondary outcomes (3)
Change in serum procollagen type I intact N-terminal propeptide (P1NP) levels (mcg/L)
P1NP is a marker of bone turnover.
Measured: Baseline and 12 months
Change in serum C-terminal telopeptide of type I collagen (CTX-1) levels (pg/mL)
CTX-1 is a marker of bone turnover.
Measured: Baseline and 12 months
Change in quality of life as assessed by Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) questionnaire
CFRSD-CRISS is a brief survey to assess quality of life of people with cystic fibrosis that will be taken by participants twice per month. The questionnaire is scored from 0-100 with higher scores indicating increased symptom severity.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start2 May 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Malinda Wu, MD, MSc, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704036
- Sponsor's protocol ID
- IRB00307525
- Acronym
- STURDY
- Status last verified
- Nov 2025
- First submitted
- 10 Jan 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Supplementation and Bone Health in Women With CF (STURDY)
- ClinicalTrials.gov ID
- NCT05704036
- Acronym / sponsor ID
- STURDY / IRB00307525
- Conditions
- Cystic Fibrosis, Hypoestrogenism
- Keywords
- Bone Mineral Density, Osteoporosis, Young Adult, Adolescent, Premenopause, Estradiol, Bone Disease, Bone Diseases, Metabolic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 2 May 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Study | No intervention | –Participants will complete three study visits (baseline, 6 months, and 12 months) involving DXAs (bone density assessment), x-rays, blood draws, and questionnaires. |
| Transdermal Estradiol/Cyclic Progesterone | Experimental | Drug: Transdermal estrogen, Drug: ProgesteroneParticipants will apply transdermal estradiol patches (0.1 mg/day) weekly for 12 months following baseline study visits. Participants not already using a progesterone-containing contraceptive will also take progesterone (200 mg) for 10 days per month. |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal estrogenAlso: Transdermal estradiol, ClimaraTransdermal estradiol 0.1 mg/day, applied once weekly | Drug | Transdermal Estradiol/Cyclic Progesterone |
| ProgesteroneAlso: PrometriumProgesterone 200 mg daily for 10 days/month, if participant is not on progesterone-containing contraceptive | Drug | Transdermal Estradiol/Cyclic Progesterone |
Primary outcome
Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline and 12 months
3 secondary outcomes
Change in serum procollagen type I intact N-terminal propeptide (P1NP) levels (mcg/L)
Time frame: Baseline and 12 months
Change in serum C-terminal telopeptide of type I collagen (CTX-1) levels (pg/mL)
Time frame: Baseline and 12 months
Change in quality of life as assessed by Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) questionnaire
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malinda Wu, MD, MSc principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transdermal estrogen and Progesterone in people with Cystic Fibrosis and Hypoestrogenism, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Wang (410-929-3056, cwang202@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.