Pregnancy and Lactation- Associated Osteoporosis

N/AActive Not RecruitingNCT07031557

Parma University Hospital1,230 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,230

Conditions

Osteoporosis and Fracture Risk in Pregnant Women

Interventions

EchoStation Implementing REMS TechnologyDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Signature informed consent * Willingness to participate in the study and ability to complete the study-related questionnaires * Women in the first trimester of pregnancy at the time of inclusion in the study * Age between 18 and 45 years at the time of recruitment in the study * Absence of secondary osteoporosis (induced by diseases or medication use) * Absence of current or past conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver diseases) * Women of normal weight or with class I obesity (BMI between 18,5 and 34) Exclusion Criteria: * Absence of informed consent * Low compliance and/or inability to complete the study-related questionnaires * Women not beyond the first trimester of pregnancy and pregnancy-related or pre-existing comorbidities * Age under 18 or over 45 years * BMI less than 18.5 or greater than 34

Outcomes

Primary Outcomes

Calcium- intake Questionnaire

Daily calcium intake will be estimated using a semi-quantitative dietary questionnaire developed by the Fragility Fracture Observatory (OFF). The questionnaire collects data on the consumption frequency and portion size of calcium-rich foods. Results will be analyzed to determine whether calcium intake meets the physiological needs during pregnancy and breastfeeding. There is no predefined score; intake will be expressed in estimated milligrams (mg) of calcium per day based on food composition and reported consumption patterns.