NCT07508553 Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination
| NCT ID | NCT07508553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-23 |
| Primary Completion | 2026-12-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-23 with a primary completion date of 2026-12-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
INCLUSION CRITERIA 1. Signed informed consent 2. Willingness to participate in the study and ability to complete the study questionnaires 3. Women between 35 and 41 weeks of gestational age at the time of study inclusion 4. Singleton or twin pregnancy (dichorionic or monochorionic) 5. Age between 30 and 45 years at the time of study recruitment 6. No history of recent or previous bone fractures or traumatic fractures, and no motor disabilities (in the mother). 7. Absence of a diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS). 8. No intake of vitamin D or other medications during pregnancy. 9. Absence of current or previous conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver disease). 10. Women of normal weight or with class I obesity (BMI between 18.5 and 34). EXCLUSION CRITERIA Patients will not be included in the study if at least one of the following exclusion criteria is met: 1. Failure to sign the informed consent form 2. Poor compliance and/or inability to complete the study questionnaires 3. Women with previous or newly diagnosed comorbidities during pregnancy 4. Age \<30 and \>45 years 5. Previous diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS) 6. BMI \<18.5 or \>34
Contact & Investigator
Tullio Ghi
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07508553 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 45 Years, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07508553 currently recruiting?
Yes, NCT07508553 is actively recruiting participants. Contact the research team at tullio.ghi@policlinicogemelli.it for enrollment information.
Where is the NCT07508553 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07508553 clinical trial?
NCT07508553 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Tullio Ghi at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 100 participants.