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:
Parma University Hospital
Organization:
Study Overview
Official Title:
Osteoporosis Project in Pregnancy and Lactation (POI)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POI
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: