Pregnancy and Lactation- Associated Osteoporosis

NCT ID: NCT07031557

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2026-09-08

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant and Breastfeeding Women

Participants in this cohort are pregnant women enrolled during their first trimester and followed up through the third trimester and the breastfeeding period. They will undergo a structured assessment of bone health, including completion of

• two standardized questionnaires, Calcium Intake and Dietary Habits Questionnaire, based on the PREDIMED score to assess adherence to the Mediterranean diet;
• AFEF Questionnaire (Algorithm for Fracture Risk in Women of Fertile Age), to evaluate clinical, anthropometric, pharmacological and lifestyle risk factors for fragility fractures.

Additionally, they will use REMS technology to monitor bone health, with periodic evaluations (first trimester, third trimester, and six months postpartum) for bone mineral density (BMD, g/cm²) and Fragility Score (0-100 scale) measurements.

EchoStation Implementing REMS Technology

Intervention Type: DEVICE

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.

Nutritional and Fracture Risk Assessment Questionnaires

Intervention Type: OTHER

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)

Interventions

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.

Intervention Type: DEVICE

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)

Intervention Type: OTHER

Other Intervention Names

EchoStation (Echolight S.p.A.)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Parma University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tullio Ghi

Principal Investigator, Medical Doctor, Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tullio Ghi

Parma, Italy/Parma, Italy

Countries

Italy

Other Identifiers

POI

Identifier Type: -

Identifier Source: org_study_id