Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination
Pregnancy-associated Reduction in Bone Mineral Density: a Comparative Study Using REMS Technology Between Singleton and Twin Pregnancies in the Third Trimester
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
100 participants
Dec 23, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- Signed informed consent
- Willingness to participate in the study and ability to complete the study questionnaires
- Women between 35 and 41 weeks of gestational age at the time of study inclusion
- 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).
Exclusion Criteria6
- 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
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Interventions
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.
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
Locations(1)
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NCT07508553