Estrogen Supplementation and Bone Health in Women With CF

This study is looking at how estrogen and other hormones affect bone development in adolescent and young adult women with cystic fibrosis (CF). Researchers want to understand how different birth control methods impact bone health, and if using transdermal estradiol (an estrogen skin patch) is practical and helpful for bone health and quality of life in this group. The study plans to enroll 75 women with CF who have had at least one menstrual cycle. The main goal is to see how much a woman's lumbar spine bone mineral density (a measure of bone strength) changes over 12 months. The study status is currently unclear.

Study design: This is an interventional study with a planned enrollment of 75 women. It includes an observational study and a feasibility sub-study.
What's involved: Participants in the observational study will have three visits (at the start, 6 months, and 12 months). At each visit, you will have blood drawn and complete questionnaires.
Compensation: Not stated in the trial record.
Follow-up: Your lumbar spine bone mineral density will be measured at the beginning of the study and again at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Estrogen Supplementation and Bone Health in Women With CF

Recruiting

PHASE4Ages 0+InterventionalTreatment

Johns Hopkins University

~75 participants

Updated 2025-11-14 on ClinicalTrials.gov

What's tested:Transdermal estrogenProgesterone

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over Baseline and 12 months

Conditions

Cystic Fibrosis

Hypoestrogenism

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Malinda Wu, MD, MSc · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Cynthia Wang

[email protected]

410-929-3056

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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)

Exclusion

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

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

What this trial measures

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

Trialytics