Effects of estrogen on bone health in women with cystic fibrosis
Estrogen Supplementation and Bone Health in Women With CF (STURDY)
This study is testing how estrogen and hormonal birth control affect bone health in young women with cystic fibrosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 0 Years to 100 Years |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05704036 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are females with cystic fibrosis who have had at least one menstrual cycle and are planning to use the same formulation of estrogen supplementation throughout the study.
Not a fit: Patients currently using anti-osteoporosis therapy or those who are pregnant or planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve bone health and quality of life for women with cystic fibrosis.
How similar studies have performed: Other studies have explored hormonal impacts on bone health, but this specific approach focusing on cystic fibrosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.