Bone mineral density in late pregnancy: singleton versus twin gestations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Women between 35 and 41 weeks of gestation will complete two Fragility Fracture Observatory (OFF) questionnaires covering dietary calcium intake, Mediterranean diet adherence (Predimed), and a fracture-risk algorithm (AFEF), and will undergo a radiation-free REMS bone densitometry exam. Clinical, obstetric, demographic, and anthropometric data including age, BMI, medical and medication history will be recorded at enrollment. The primary comparison is third-trimester BMD between singleton and dichorionic/monochorionic twin pregnancies, with secondary analyses relating BMD to questionnaire scores and maternal clinical factors. Results aim to clarify relationships between pregnancy type, maternal factors, and bone health near term.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS
  Roma, Rm, Italy Recruiting

Study contacts

• Principal investigator: Tullio Ghi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Tullio Ghi
• Email: tullio.ghi@policlinicogemelli.it
• Phone: 0630155989

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.