NCT07031557

Pregnancy and Lactation- Associated Osteoporosis

Osteoporosis Project in Pregnancy and Lactation (POI)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,230 (actual)
• Sponsor: Parma University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis and Fracture Risk in Pregnant Women

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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)

Timeline

• Start date: 2024-09-09
• Primary completion: 2025-09-08
• Completion: 2026-09-08
• First posted: 2025-06-22
• Last updated: 2025-09-05

Locations

1 site across 1 country: Italy