Advancing Early Bone Health: New Frontiers for Osteoporosis Prevention (NCT06750523) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Advancing Early Bone Health: New Frontiers for Osteoporosis Prevention
Italy200 participantsStarted 2023-05-17
Plain-language 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.
Who can participate
Age range
37 Weeks – 42 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* preterm infants
* Infants hospitalized since birth for special conditions
* infants with metabolic disorders
* infants with genetic syndromes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone Mineral Density (BMD)
Timeframe: >37 and <42 weeks; 48 hours; 1, 3, 6, and 12 months
2
MicroRNA assay on umbilical cord blood
Timeframe: at birth
3
Endocrine disruptors (EDCs) on umbilical cord blood at birth.
Timeframe: at birth
4
Endocrine disruptors (EDCs) on urine at 1 months of age.