Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07010146 · ClinicalTrials.gov registry record · Phase 2
Role of Estrogen on Skeletal Outcomes in FHA
A Phase 2 study of Bone Density and Bone Strength, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT07010146: Recruiting Phase 2 study of Bone Density and Bone Strength, sponsored by University of Virginia.
NCT07010146 is a Phase 2 study of Bone Density and Bone Strength that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 150 participants, below the 3,746-participant average among 7 other Bone Density trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07010146, a Phase 2 study of Bone Density and Bone Strength, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control. Participants will: Take estrogen for 1 year either (i) in its natural form as a patch twice a week (and progesterone by mouth for 12 days of each month), or (ii) in its natural form as a pill daily (and progesterone by mouth for 12 days of each month), or (iii) in a synthetic form as a birth control patch weekly for 3 weeks with 1 week off the patch. You will not be able to choose which form of estrogen you will receive as this will be assigned to you based on a pre-existing randomization sequence (like the flip of a coin) Take provided calcium and vitamin D supplements Attend 4 study visits over 12 months with two at the beginning and then every 6 months that include: History and Physical Exams Lab Work Imaging studies Questionnaires Dietary recalls
Primary Outcome
Using repeated measures analysis, the investigators will compare change in lumbar spine, total hip and femoral neck BMD and trabecular bone score after 12 months of treatment between the transdermal 17β-E2 group and each of the oral 17β-E2 and transdermal EE+LNG groups. BMD and TBS are assessed using DXA. Unit for BMD is g/cm2.
Conditions Studied
Interventions
- DRUG transdermal 17β-E2 with cyclic progestin
- DRUG oral 17β-E2 with cyclic progestin
- DRUG transdermal EE+LNG
Study Locations (2)
Virginia
- University of Virginia Medical Center - Charlottesville
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 2 |
What NCT07010146 shows while recruiting
NCT07010146 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 3,746-participant average among 7 other Bone Density trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Bone Density appearing as the primary indexed condition, and to 3 interventions - of which transdermal 17β-E2 with cyclic progestin is the first listed.
NCT07010146 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT07010146 about?
NCT07010146 is a clinical study titled "Role of Estrogen on Skeletal Outcomes in FHA". The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl...
What is the current status of trial NCT07010146?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-07-01. Estimated completion is 2030-07-01.
What conditions does trial NCT07010146 study?
This clinical trial studies the following conditions: Bone Density, Bone Strength, FHA (Functional Hypothalamic Amenorrhea).
What interventions are being tested in trial NCT07010146?
The interventions under investigation include: transdermal 17β-E2 with cyclic progestin (DRUG), oral 17β-E2 with cyclic progestin (DRUG), transdermal EE+LNG (DRUG).
Who is sponsoring clinical trial NCT07010146?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07010146 being conducted?
This trial has 2 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bone Density
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Metabolic Health, Bones and Nuts During Weight Loss in Adults
RECRUITING · NA
-
Bone Metabolism in 12-21 Year Olds Undergoing GLP-1 Receptor Agonist Therapy
RECRUITING
-
VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL)
ACTIVE NOT RECRUITING · NA
-
Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults
ACTIVE NOT RECRUITING · NA
-
Low Energy Availability, Menstrual Irregularity, and Low Bone Mass
COMPLETED
-
The Effect of Weight Loss and Dietary Protein Intake on Bone
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI