Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pre… (NCT07508553) | Clinical Trial Compass
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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
Italy100 participantsStarted 2025-12-23
Plain-language 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.
Who can participate
Age range30 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Failure to sign the informed consent form
✕
What they're measuring
1
BMD differences between singleton and twin pregnancies
Timeframe: From enrollment through delivery, an average of six weeks
. 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)