Recruiting

Estrogen with Bone Health

Sponsor:

Johns Hopkins University

Code:

NCT05704036

Conditions

Cystic Fibrosis

Hypoestrogenism

Eligibility Criteria

Sex: Female

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Transdermal estrogen

Progesterone

Study Details

Brief 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. 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

Cystic Fibrosis

Hypoestrogenism

Study ID

NCT05704036

Start date

May 2, 2023

Status verified date

Nov, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0 - 70+

Healthy Volunteers: Not accepted

Observational Study:

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Observational Study

Participants will complete three study visits (baseline, 6 months, and 12 months) involving DXAs (bone density assessment), x-rays, blood draws, and questionnaires.

experimental: Transdermal Estradiol/Cyclic Progesterone

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.

Interventions

Transdermal estrogen

Transdermal estradiol 0.1 mg/day, applied once weekly

Progesterone

Progesterone 200 mg daily for 10 days/month, if participant is not on progesterone-containing contraceptive

Primary outcome measure

  • Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA) [ Time Frame: Baseline and 12 months ]

Central Contacts and Locations

Central contacts

Cynthia Wang

410-929-3056cwang202@jh.edu

Locations

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Cynthia Wang

410-929-3056cwang202@jh.edu

Principal Investigator:

Malinda Wu, MD, MSc

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • Bone Mineral Density
  • Osteoporosis
  • Young Adult
  • Adolescent
  • Premenopause
  • Estradiol
  • Bone Disease
  • Bone Diseases, Metabolic
  • Hormones
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-14.