Osteoporosis Project in Pregnancy and Lactation (POI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,230
- 试验地点
- 1
- 主要终点
- Calcium- intake Questionnaire
研究概览
简要总结
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:
- Questionnaires on calcium intake, dietary habits (Predimed), and fracture risk (AFEF);
- Ultrasound densitometry (REMS) in the first and third trimester of pregnancy and during breastfeeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Calcium- intake Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Tullio Ghi
Principal Investigator, Medical Doctor, Professor of Obstetrics and Gynecology
Parma University Hospital