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

NCT07508553 | Recruiting

• 1 other identifier: 8084
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Osteoporosis; Pregnancy; Twin Pregnancy

Keywords

pregnancy; twin pregnancy; bone mineral density; ultrasound densitometry

Outcome Measures

Primary Outcomes (1)

• BMD differences between singleton and twin pregnancies

  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 a singleton pregnancy and women with dichorionic and monochorionic twin pregnancies.

  From enrollment through delivery, an average of six weeks

Secondary Outcomes (2)

• BMD values and maternal clinical parameter

  From enrollment through delivery, an average of six weeks

• Correlation between bone mineral density (DEXA, g/cm²) and validated questionnaire scores (calcium intake, PREDIMED, AFEF)

  From enrollment through delivery, an average of six weeks

Study Arms (2)

singleton pregnancy

EXPERIMENTAL

Women in physiological pregnancy between the 35th and 41st week, with a single pregnancy

Device: bone densitometric examination using REMS technology; Other: questionnaires

Twin pregnancy

EXPERIMENTAL

Women in physiological pregnancy between the 35th and 41st week, with a single pregnancy

Device: bone densitometric examination using REMS technology; Other: questionnaires

Interventions

bone densitometric examination using REMS technology DEVICE

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.

Twin pregnancy; singleton pregnancy

questionnaires OTHER

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

Twin pregnancy; singleton pregnancy

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent
• Willingness to participate in the study and ability to complete the study questionnaires
• Singleton or twin pregnancy (dichorionic or monochorionic)
• Age between 30 and 45 years at the time of study recruitment
• No history of recent or previous bone fractures or traumatic fractures, and no motor disabilities (in the mother).
• Absence of a diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS).
• No intake of vitamin D or other medications during pregnancy.
• Absence of current or previous conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver disease).
• Women of normal weight or with class I obesity (BMI between 18.5 and 34).

You may not qualify if:

• Failure to sign the informed consent form
• Poor compliance and/or inability to complete the study questionnaires
• Women with previous or newly diagnosed comorbidities during pregnancy
• Age \<30 and \>45 years
• Previous diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS)
• BMI \<18.5 or \>34

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tullio Ghi

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tullio Ghi

CONTACT

0630155989; tullio.ghi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: April 2, 2026
• Study Start: December 23, 2025
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2027
• Last Updated: April 2, 2026

Record last verified: 2025-12

Locations

IT (1)