Comparing Bone Density in Late Pregnancy Between Women Carrying One Baby or Twins
Compares bone density in late pregnancy between women carrying one baby or twins.
Plain-language title generated from the registry record
Registry title: Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination
Key facts
- Where
- Roma, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 45 years old?
Source: NCT07508553, who can take part
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCSRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07508553
- Record updated
- 2 April 2026
- Original description
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:Read full original descriptionShow less
Pregnancy-associated Reduction in Bone Mineral Density: a Comparative Study Using REMS Technology Between Singleton and Twin Pregnancies in the Third Trimester
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.
Inclusion: 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: Women with previous or newly diagnosed comorbidities during pregnancy; Previous diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS); Failure to sign the informed consent form; Age <30 and >45 years; Patients will not be included in the study if at least one of the following exclusion criteria is met:; Poor compliance and/or inability to complete the study questionnaires; BMI <18.5 or >34.