MedTrace Logo

Pregnancy and Lactation- Associated Osteoporosis

NCT07031557 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1230

Last updated 2025-09-05

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Parma University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2025-09-08
Completion
2026-09-08

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07031557 on ClinicalTrials.gov