Osteoporosis and Fracture Risk in Pregnant Women
Conditions
Keywords
Pregnancy-Associated Osteoporosis, REMS
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.
Interventions
DEVICEEchoStation 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.
OTHERNutritional 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
Parma University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcium- intake Questionnaire | Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum | 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. |
| AFEF Questionnaire | Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum | Fracture risk will be assessed through the AFEF (Algorithm for Fracture Risk in Women of Fertile Age) questionnaire developed by the Fragility Fracture Observatory (OFF). The questionnaire is a non-scoring, structured tool collecting detailed information on anthropometrics (e.g., weight and height), personal and family medical history, lifestyle factors (e.g., smoking), and pharmacological treatments before and during pregnancy. No numerical score is generated. Risk profiles will be evaluated qualitatively based on the presence or absence of recognized clinical risk factors for fragility fractures. |
| PREDIMED Score for Mediterranean Diet Adherence | Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum | Adherence to the Mediterranean diet will be assessed using the validated PREDIMED questionnaire, which includes 14 items evaluating dietary habits. Each item is scored as 1 (adherent) or 0 (non-adherent), for a total score ranging from 0 to 14. Scores are interpreted as follows: ≤5 = Low adherence, 6-9 = Moderate adherence, ≥10 = High adherence. Higher scores indicate better adherence to the Mediterranean diet. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Mineral Density (BMD) at the Proximal Femur Assessed by REMS During Pregnancy and Breastfeeding | Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum | To monitor longitudinal changes in bone structure by measuring Bone Mineral Density (BMD unit g/cm²) using Radiofrequency Echographic Multi Spectrometry (REMS) at the proximal femur. Assessments will occur during the first trimester, third trimester of pregnancy and during breastfeeding. Results will be reported separately for participants stratified into two baseline BMD groups (normal vs. reduced). |
| Fragility Score (FS) Measured by REMS at the Proximal Femur During Pregnancy and Breastfeeding | Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum | To evaluate the risk factors that lead to variations in bone fragility, through the use of the REMS-based Fragility Score (FS) parameter, identifying the cut-off value for femoral FS specific to pregnant women. Unit of Measure of Fragility Score (FS), scale 0-100, where higher FS values represent increased fragility. |
Countries
Italy
Outcome results
None listed