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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Maximum Age: 100
Healthy Volunteers: f
View:

• 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)

Locations
United States
Maryland
Johns Hopkins
RECRUITING
Baltimore
Contact Information
Primary
Cynthia Wang
cwang202@jh.edu
410-929-3056
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2027-01
Participants
Target number of participants: 75
Treatments
No_intervention: Observational Study
Participants will complete three study visits (baseline, 6 months, and 12 months) involving DXAs (bone density assessment), x-rays, blood draws, and questionnaires.
Experimental: Transdermal Estradiol/Cyclic Progesterone
Participants will apply transdermal estradiol patches (0.1 mg/day) weekly for 12 months following baseline study visits. Participants not already using a progesterone-containing contraceptive will also take progesterone (200 mg) for 10 days per month.
Related Therapeutic Areas
Sponsors
Collaborators: Cystic Fibrosis Foundation
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov