Advancing Early Bone Health: New Frontiers for Osteoporosis Prevention

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.

Conditions

• Low-Risk Pregnant Women at Full-Term Gestation
• Healthy Fetal Population
• Healthy Neonatal Population

Interventions

DIAGNOSTIC_TEST

Cord blood sampling

A cord blood sample will be taken at birth for analysis of oxidative stress markers, endocrine disruptors, and microRNAs.

DIAGNOSTIC_TEST

urine sampling

At one month of age, urine samples will be collected from newborns to analyze oxidative stress markers and endocrine disruptors.

BEHAVIORAL

Life style questionnaire

At the time of enrollment, mothers will complete a specialized questionnaire designed to assess potential exposure to endocrine disruptors (EDCs) through diet, clothing, and the use of cosmetics and detergents.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma

  collaborator OTHER

• Azienda Ospedaliera Universitaria Policlinico "G. Martino"

  collaborator OTHER

• University of Parma

  lead OTHER

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

37 Weeks

Max Age

42 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-17

Primary Completion

2025-06-30

Completion

2025-11-30

Countries

• Italy

Study Locations