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NCT Number: NCT07031557

Pregnancy and Lactation- Associated Osteoporosis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoporosis and Fracture Risk in Pregnant Women Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Tullio Ghi

Parma, Italy/Parma, 43126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: EchoStation (Echolight S.p.A.)

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)

Primary outcomes

  1. Calcium- intake Questionnaire

    Time frame: 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.

  2. AFEF Questionnaire

    Time frame: 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.

  3. PREDIMED Score for Mediterranean Diet Adherence

    Time frame: 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 outcomes

  1. Change in Bone Mineral Density (BMD) at the Proximal Femur Assessed by REMS During Pregnancy and Breastfeeding

    Time frame: 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).

  2. Fragility Score (FS) Measured by REMS at the Proximal Femur During Pregnancy and Breastfeeding

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Parma University Hospital

Other

Registry information

Official study title

Osteoporosis Project in Pregnancy and Lactation (POI)

Acronym: POI

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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