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NCT07031557

Pregnancy and Lactation- Associated Osteoporosis

Sponsor: Parma University Hospital

View on ClinicalTrials.gov

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

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)

Locations (1)

Tullio Ghi

Parma, Italy/Parma, Italy