Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 6:54 PM
Study NCT ID:
NCT07031557
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy and Lactation- Associated Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1230}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-09-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcium- intake Questionnaire', 'timeFrame': 'Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum', 'description': '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.\n\nThere is no predefined score; intake will be expressed in estimated milligrams (mg) of calcium per day based on food composition and reported consumption patterns.'}, {'measure': 'AFEF Questionnaire', 'timeFrame': 'Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum', 'description': '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.\n\nNo numerical score is generated. Risk profiles will be evaluated qualitatively based on the presence or absence of recognized clinical risk factors for fragility fractures.'}, {'measure': 'PREDIMED Score for Mediterranean Diet Adherence', 'timeFrame': 'Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum', 'description': '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.\n\nScores are interpreted as follows: ≤5 = Low adherence, 6-9 = Moderate adherence, ≥10 = High adherence.\n\nHigher scores indicate better adherence to the Mediterranean diet.'}], 'secondaryOutcomes': [{'measure': 'Change in Bone Mineral Density (BMD) at the Proximal Femur Assessed by REMS During Pregnancy and Breastfeeding', 'timeFrame': 'Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum', 'description': '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).'}, {'measure': 'Fragility Score (FS) Measured by REMS at the Proximal Femur During Pregnancy and Breastfeeding', 'timeFrame': 'Baseline (First Trimester, ≤12 weeks), Third Trimester (Weeks 28-40), and 6 Months Postpartum', 'description': '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.\n\nUnit of Measure of Fragility Score (FS), scale 0-100, where higher FS values represent increased fragility.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy-Associated Osteoporosis', 'REMS'], 'conditions': ['Osteoporosis and Fracture Risk in Pregnant Women']}, 'descriptionModule': {'briefSummary': '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.\n\nThe study aims to monitor bone mineral density (BMD) and fracture risk in pregnant and breastfeeding women using:\n\n1. Questionnaires on calcium intake, dietary habits (Predimed), and fracture risk (AFEF);\n2. Ultrasound densitometry (REMS) in the first and third trimester of pregnancy and during breastfeeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signature informed consent\n* Willingness to participate in the study and ability to complete the study-related questionnaires\n* Women in the first trimester of pregnancy at the time of inclusion in the study\n* Age between 18 and 45 years at the time of recruitment in the study\n* Absence of secondary osteoporosis (induced by diseases or medication use)\n* Absence of current or past conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver diseases)\n* Women of normal weight or with class I obesity (BMI between 18,5 and 34)\n\nExclusion Criteria:\n\n* Absence of informed consent\n* Low compliance and/or inability to complete the study-related questionnaires\n* Women not beyond the first trimester of pregnancy and pregnancy-related or pre-existing comorbidities\n* Age under 18 or over 45 years\n* BMI less than 18.5 or greater than 34'}, 'identificationModule': {'nctId': 'NCT07031557', 'acronym': 'POI', 'briefTitle': 'Pregnancy and Lactation- Associated Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Parma University Hospital'}, 'officialTitle': 'Osteoporosis Project in Pregnancy and Lactation (POI)', 'orgStudyIdInfo': {'id': 'POI'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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\n\n* two standardized questionnaires, Calcium Intake and Dietary Habits Questionnaire, based on the PREDIMED score to assess adherence to the Mediterranean diet;\n* AFEF Questionnaire (Algorithm for Fracture Risk in Women of Fertile Age), to evaluate clinical, anthropometric, pharmacological and lifestyle risk factors for fragility fractures.\n\nAdditionally, 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.', 'interventionNames': ['Device: EchoStation Implementing REMS Technology', 'Other: Nutritional and Fracture Risk Assessment Questionnaires']}], 'interventions': [{'name': 'EchoStation Implementing REMS Technology', 'type': 'DEVICE', 'otherNames': ['EchoStation (Echolight S.p.A.)'], 'description': '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.', 'armGroupLabels': ['Pregnant and Breastfeeding Women']}, {'name': 'Nutritional and Fracture Risk Assessment Questionnaires', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Pregnant and Breastfeeding Women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43126', 'city': 'Parma', 'state': 'Italy/Parma', 'country': 'Italy', 'facility': 'Tullio Ghi', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parma University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Medical Doctor, Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Tullio Ghi', 'investigatorAffiliation': 'Parma University Hospital'}}}}