Clinical Trial

Advancing Early Bone Health: New Frontiers for Osteoporosis Prevention

Study acronym: REMS-BONE
Active, Not Recruiting
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Record status
This record was last updated January 1, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
Summary
All factors that influence the peak bone mass achieved at skeletal maturity are important in determining an individual's risk of developing osteoporosis later in life. Bone health begins with maternal health and nutrition, which influence skeletal mass and bone density in utero. The mechanisms underlying the effect of the intrauterine environment on bone health are currently unknown, but certainly include 'fetal programming' of oxidative stress and endocrine systems, as these influence skeletal growth and development later in life. For the prevention of bone health, the challenges rely 1) in the need for new technology and software specific and applicable to the fetus and newborn; 2) in establishing the effect of environmental contaminants, in particular endocrine disruptors, oxidative stress and subsequent epigenetic changes in mothers and subsequently on the fetus, newborn and infant.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-24.
Trial Details
NCT Number NCT06750523
Lead Sponsor University of Parma
Collaborators: Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Conditions Low-Risk Pregnant Women at Full-Term Gestation, Healthy Fetal Population, Healthy Neonatal Population
Enrollment 200 participants
Start Date 2023-05-17
Primary Completion 2025-06 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2025-01-01