Estrogen Supplementation and Bone Health in Women With CF

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05704036
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cystic Fibrosis
  • Hypoestrogenism

Eligibility Criteria

Sex
FEMALE
Age
0 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Transdermal estrogen — DRUG
    Transdermal estradiol 0.1 mg/day, applied once weekly
  • Progesterone — DRUG
    Progesterone 200 mg daily for 10 days/month, if participant is not on progesterone-containing contraceptive

Study Details

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.

Key Dates

Start date
May 2, 2023
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA) [ Time Frame: Baseline and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21287
Cynthia Wang
[email protected]
410-929-3056
Malinda Wu, MD, MSc (PRINCIPAL_INVESTIGATOR)

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