Estrogen Supplementation and Bone Health in Women With CF

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.

Conditions

• Cystic Fibrosis
• Hypoestrogenism

Interventions

DRUG

Transdermal estrogen

Transdermal estradiol 0.1 mg/day, applied once weekly

DRUG

Progesterone

Progesterone 200 mg daily for 10 days/month, if participant is not on progesterone-containing contraceptive

Sponsors & Collaborators

• Cystic Fibrosis Foundation

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Malinda Wu, MD, MSc · Johns Hopkins University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

0 Years

Max Age

100 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-02

Primary Completion

2027-01-31

Completion

2027-01-31

FDA Drug

Yes

Countries

• United States

Study Locations