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Can estrogen patches strengthen bones in women with CF?

NCT ID NCT05704036

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how estrogen and other hormones affect bone development in teenage and young adult women with cystic fibrosis (CF). It has two parts: an observational study that tracks bone health in women using different types of birth control, and a small feasibility study where participants use estrogen skin patches for a year. Researchers will measure bone density, blood markers, and quality of life to see if estrogen therapy is helpful and practical for this group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic bone disorder cystic fibrosis osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis Hypoestrogenism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

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