Clinical Trial

Pregnancy and Lactation- Associated Osteoporosis

Study acronym: POI
Active, Not Recruiting
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Record status
This record was last updated September 5, 2025 (before its estimated September 8, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-12.
Trial Details
NCT Number NCT07031557
Lead Sponsor Parma University Hospital
Conditions Osteoporosis and Fracture Risk in Pregnant Women
Enrollment 1,230 participants
Start Date 2024-09-09
Primary Completion 2025-09-08 (estimated)
Study Completion 2026-09-08 (estimated)
Updated on ClinicalTrials.gov 2025-09-05