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

Recruiting now · Not applicable

Conditions studied: Osteoporosis, Pregnancy, Twin Pregnancy

In brief

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.

Key facts

Study ID

NCT07508553

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

100

Starts

2025-12-23

Expected to finish

2027-12-23

Last updated by the study team

2026-04-02

Who can join

Age: 30 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• Patients will not be included in the study if at least one of the following exclusion criteria is met:
• 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

Where it is running

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.