NCT07031557Active, not recruiting
Pregnancy and Lactation- Associated Osteoporosis
Osteoporosis Project in Pregnancy and Lactation (POI)
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
Pregnancy-Associated Osteoporosis is a condition characterized by loss of bone mass and fragility fractures during pregnancy or breastfeeding, often due to the increased calcium request from fetus. It typically manifests from the third trimester of pregnancy or in the early months of breastfeeding. Therefore, early diagnosis is crucial to prevent fractures and vertebral collapses. The study aims to monitor bone mineral density (BMD) and fracture risk in pregnant and breastfeeding women using: 1. Questionnaires on calcium intake, dietary habits (Predimed), and fracture risk (AFEF); 2. Ultrasound densitometry (REMS) in the first and third trimester of pregnancy and during breastfeeding.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1230 (actual)
- First submitted
- 3 Mar 2025
- Start date
- 9 Sept 2024
- Primary completion date
- 8 Sept 2025
- Lead sponsor
- Parma University Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT07031557
What you commit to
- Study type: Observational
- Participants enrolled: 1230
- From 9 Sept 2024 to the primary completion date, 8 Sept 2025
- 1 site 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.
Age
- Age under 18 or over 45 years
Other
- Absence of informed consent
- Low compliance and/or inability to complete the study-related questionnaires
- Women not beyond the first trimester of pregnancy and pregnancy-related or pre-existing comorbidities
- BMI less than 18.5 or greater than 34
Who the study is looking for
- Signature informed consent
- Willingness to participate in the study and ability to complete the study-related questionnaires
- Women in the first trimester of pregnancy at the time of inclusion in the study
- Age between 18 and 45 years at the time of recruitment in the study
- Absence of secondary osteoporosis (induced by diseases or medication use)
- Absence of current or past conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver diseases)
- Women of normal weight or with class I obesity (BMI between 18,5 and 34)
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tullio Ghi Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.