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NCT Number: NCT05704036

Estrogen Supplementation and Bone Health in Women With CF

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.

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Key information

Conditions

Cystic Fibrosis Bone Diseases Bone Diseases, Metabolic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Hypoestrogenism Infant, Newborn, Diseases Lung Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Pancreatic Diseases Respiratory Tract Diseases

Age range

0 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Cynthia Wang

CONTACT

[email protected]

410-929-3056

Malinda Wu, MD, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal estrogen

Drug

Transdermal estradiol 0.1 mg/day, applied once weekly

Other names: Transdermal estradiol, Climara

Progesterone

Drug

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

Other names: Prometrium

Primary outcomes

  1. Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA)

    Time frame: Baseline and 12 months

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Wang

CONTACT

[email protected]

410-929-3056

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

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

Acronym: STURDY

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2023
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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