NCT07508553Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 23 Dec 2025
- Start date
- 23 Dec 2025
- Primary completion date
- 23 Dec 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Osteoporosis
- NCT number
- NCT07508553
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 23 Dec 2025 to the primary completion date, 23 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Failure to sign the informed consent form
Age
- Age \<30 and \>45 years
Other
- 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
Who the study is looking for
- 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).
Age in the registry: 30 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.