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Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination

NCT07508553 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-02

No results posted yet for this study

Summary

This clinical study aims to monitor and evaluate bone mineral density and fracture risk in women with singleton and twin pregnancies through the combined use of:

* two specific questionnaires developed by the Fragility Fracture Observatory (OFF), and
* a bone densitometric examination using REMS technology, performed between the 35th and 41st week of gestation.

Primary objective:

• To identify, in the third trimester of pregnancy (between the 35th and 41st gestational week), any differences in bone mineral density (BMD) between women with singleton pregnancies and women with dichorionic and monochorionic twin pregnancies.

Secondary objectives:

* Evaluate the relationship between bone mineral density (BMD) values and maternal clinical and historical parameters, such as age, body mass index (BMI), and obstetric and medical history.
* Evaluate the association between BMD values and scores obtained from validated questionnaires administered to investigate fracture risk and bone health-related quality of life in women with singleton and twin pregnancies.

Conditions

Interventions

DEVICE

bone densitometric examination using REMS technology

An assessment of bone health using ultrasound densitometry using REMS technology, integrated into the EchoStation device (Echolight Spa, Lecce, Italy), is performed during the third trimester check-up. Thanks to an innovative parameter called Fragility Score (FS), intrinsically correlated with bone quality and independent of BMD, REMS allows assessment of bone fragility and its resulting fracture risk, representing a useful diagnostic tool also in predicting the risk of fragility fractures.

OTHER

questionnaires

Specific questionnaires developed by the Fragility Fracture Observatory (OFF) will be administered. Their purpose is to assess all risk factors that could lead to fractures during pregnancy, as well as to evaluate both dietary habits and adherence to the Mediterranean diet

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Tullio Ghi · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-23
Primary Completion
2026-12-23
Completion
2027-12-23

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07508553 on ClinicalTrials.gov