Pregnancy and Lactation- Associated Osteoporosis

NCT07031557 | Active Not Recruiting

• 1 other identifier: POI
• Study Type: observational
• Target: 1,230
• Locations: 1 country
• Sites: 1

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. 1.Questionnaires on calcium intake, dietary habits (Predimed), and fracture risk (AFEF);
2. 2.Ultrasound densitometry (REMS) in the first and third trimester of pregnancy and during breastfeeding.

Conditions

Osteoporosis and Fracture Risk in Pregnant Women

Keywords

Pregnancy-Associated Osteoporosis; REMS

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum

• AFEF Questionnaire

  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.

  Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum

• PREDIMED Score for Mediterranean Diet Adherence

  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.

  Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

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.

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

Interventions

EchoStation Implementing REMS Technology 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.

Also known as: EchoStation (Echolight S.p.A.)

Pregnant and Breastfeeding Women

Nutritional and Fracture Risk Assessment Questionnaires 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)

Pregnant and Breastfeeding Women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A cohort of 1230 pregnant women aged 18-45 years and BMI between 18.5 and 34 without secondary osteoporosis and potential pathological conditions that may affect bone health.

You may qualify if:

• Signature informed consent
• Willingness to participate in the study and ability to complete the study-related questionnaires
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Parma University Hospital: lead

Study Sites (1)

Tullio Ghi

Parma, Italy/Parma, 43126, Italy

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor, Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: June 22, 2025
• Study Start: September 9, 2024
• Primary Completion: September 8, 2025
• Study Completion (Estimated): September 8, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)