NCT06750523Active, not recruiting
Advancing Early Bone Health: New Frontiers for Osteoporosis Prevention
Getting Bone Health Right From the Start: Innovative Technology and New Mechanims of Mother-fetus Cross Talk for Osteopenia and Osteporosis Prevention
Source: ClinicalTrials.gov · Last updated 1 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 19 Dec 2024
- Start date
- 17 May 2023
- Primary completion date
- Jun 2025
- Lead sponsor
- University of Parma
- Diseases
- Osteoporosis
- NCT number
- NCT06750523
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 17 May 2023 to the primary completion date, Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Infants hospitalized since birth for special conditions
- infants with metabolic disorders
- infants with genetic syndromes
Other
- preterm infants
Who the study is looking for
- term infants from low-risk pregnancy
- (37-42 weeks gestational age)
- Single pregnancy
- Absence of current or previous maternal diseases that could potentially interfere with bone metabolism (e.g., thyroid, kidney, liver disease)
- Absence of motor disability of the mother
- No previous history of recent, previous bone fractures or traumatic fractures (in the mother)
- No intake of vitamin D or other medications during pregnancy
- Maternal age \>18 years
- No diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS)
Age in the registry: 37 weeks to 42 weeks · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria "Gaetano Martino" di Messina Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.