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Pregnancy and Lactation- Associated Osteoporosis
Sponsor: Parma University Hospital
Summary
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.
Official title: Osteoporosis Project in Pregnancy and Lactation (POI)
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
OBSERVATIONAL
Enrollment
1230
Start Date
2024-09-09
Completion Date
2026-09-08
Last Updated
2025-09-05
Healthy Volunteers
Yes
Interventions
EchoStation Implementing REMS Technology
Ultrasound-based densitometry used for the prevention, diagnosis, and monitoring of bone health status and fracture risk at reference anatomical sites (femur and spine), including all patient categories.
Nutritional and Fracture Risk Assessment Questionnaires
Questionnaires regarding Calcium Intake, dietary habits assessment (Predimed), and Algorithm for Fracture Risk in Women of Childbearing Age (AFEF) developed by the Fragility Fracture Observatory (OFF)
Locations (1)
Tullio Ghi
Parma, Italy/Parma, Italy