Estrogen Supplementation and Bone Health in Women With CF (STURDY)

November 13, 2025 updated by: Johns Hopkins University

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?

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Principal Investigator:
          • Malinda Wu, MD, MSc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 30 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Transdermal estrogen
Transdermal estradiol 0.1 mg/day, applied once weekly
Other Names:
  • Climara
  • Transdermal estradiol
Drug: Progesterone
Progesterone 200 mg daily for 10 days/month, if participant is not on progesterone-containing contraceptive
Other Names:
  • Prometrium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum procollagen type I intact N-terminal propeptide (P1NP) levels (mcg/L)
Time Frame: Baseline and 12 months
P1NP is a marker of bone turnover.
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
CTX-1 is a marker of bone turnover.
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
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.
Baseline and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study procedure completion rate
Time Frame: Evaluated at completion of study, approximately two years
Percentage of participants enrolled in study who complete all study procedures.
Evaluated at completion of study, approximately two years
Acceptability as determined by participant report
Time Frame: Across 12 months of study participation per participant
Acceptability during study participation by 5 point Likert scale, with a score or 3 or greater considered acceptable.
Across 12 months of study participation per participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Malinda Wu, MD, MSc, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00307525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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