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Estrogen Supplementation and Bone Health in Women With CF

Study acronym: STURDY
StatusRecruiting
PhasePhase 4
Started2023-05-02
View on ClinicalTrials.gov ↗

Amendment history

2025-11-13
Study Status v7
Primary completion date2025-12→2027-01
Completion date2025-12→2027-01
2024-11-08
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
2023-11-21
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v5
Primary completion date2024-12→2025-12
Completion date2024-12→2025-12
InterventionsPlacebo patch (Drug), Placebo pill (Drug), Progesterone (Drug), Transdermal estrogen (Drug)→Progesterone (Drug), Transdermal estrogen (Drug)
Eligibility criteria+357 characters
Observational Study: Inclusion Criteria: CF diagnosisDiagnosis 16Females 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-30osteoporosis 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 ⇅ moved In the opinion of the CF care team or study investigators participant should not participate in the st [...] [...]
Secondary endpoints5 to 3 entries
Change in serum estradiol levels (pg/mL) Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA)
Primary endpoints4 to 1 entries
AcceptabilityChange asin determinedlumbar spine bone mineral density assessed by participantdual-energy report Numberx-ray ofabsorptiometry potential participants enrolled per month Rate of screen fails Study procedure completion rate(DXA)
Study title-17 characters
Estrogen Patches for AdolescentSupplementation and YoungBone AdultHealth in Women With Cystic FibrosisCF
2023-06-09
Study Status v4
Start dateestimated 2023-06→confirmed 2023-05-02
2023-04-18
Study Status v3
Start date2023-04→2023-06
Show 2 earlier versions
2023-03-29
Study Status v2
Start date2023-03→2023-04
2023-02-24
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2023-01→2023-03
Study sitesdetails revised at 1 of 1 site
2023-01-19
Original filing
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.
Trial Details
NCT Number NCT05704036
Lead Sponsor Johns Hopkins University
Collaborators: Cystic Fibrosis Foundation
Conditions Cystic Fibrosis, Hypoestrogenism
Enrollment 75 participants
Start Date 2023-05-02
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-14