RECRUITING

Estrogen Supplementation and Bone Health in Women With CF

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-02
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05704036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * CF Diagnosis
  2. * Females who have had at least 1 menstrual cycle
  3. * Planning to use same formulation of estrogen supplementation (or none) for duration of study
  1. * Use of anti-osteoporosis therapy including anti-resorptives such as bisphosphonates or anabolic agents such as teriparatide or denosumab
  2. * Conditions in which bone loss is known to be present or expected to occur, such as lactation
  3. * Pregnant or planning to become pregnant
  4. * In the opinion of the CF care team or study investigators participant should not participate in the study
  5. * Inability to provide informed consent/assent

Contacts and Locations

Study Contact

Cynthia Wang
CONTACT
410-929-3056
cwang202@jh.edu

Principal Investigator

Malinda Wu, MD, MSc
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Malinda Wu, MD, MSc, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-02
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-05-02
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Bone Mineral Density
  • Osteoporosis
  • Young Adult
  • Adolescent
  • Premenopause
  • Estradiol
  • Bone Disease
  • Bone Diseases, Metabolic
  • Hormones
  • Quality of Life

Additional Relevant MeSH Terms

  • Cystic Fibrosis
  • Hypoestrogenism