Effects of estrogen on bone health in women with cystic fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the role of estrogen and other hormones in bone development among adolescent and young adult women diagnosed with cystic fibrosis. It includes an observational component to assess how different hormonal contraceptives affect bone health, as well as a feasibility sub-study to evaluate the impact of transdermal estradiol on bone health and quality of life. Participants will undergo multiple study visits, including blood draws, questionnaires, and bone density assessments, to gather comprehensive data over a 12-month period.

Why it matters

Who can join: the full rules

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

Where it's running

• Johns Hopkins
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Malinda Wu, MD, MSc — Johns Hopkins University
• Study coordinator: Cynthia Wang
• Email: cwang202@jh.edu
• Phone: 410-929-3056

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.