Pregnancy and Lactation- Associated Osteoporosis (POI)

Parma University Hospital

Status: Active, not recruiting

Conditions: Osteoporosis and Fracture Risk in Pregnant Women

Treatments: Device: EchoStation Implementing REMS Technology; Other: Nutritional and Fracture Risk Assessment Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT07031557

POI

Details and patient eligibility

About

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.

Enrollment: 1,230 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,230 participants in 1 patient group

Pregnant and Breastfeeding Women

Description:

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.

Treatment:

Other: Nutritional and Fracture Risk Assessment Questionnaires

Device: EchoStation Implementing REMS Technology